2 Guest editorial A cautionary tale of regulatory overreach
8 IBE Iliac branch device ‘equally effective’ in both IDE and registry studies, new data show
By Bryan Kay
NEW FINDINGS CHRONICLING PROGRESS WITH BOTH THE Gore Excluder thoracoabdominal branch endoprosthesis (TAMBE)— approved by the Food and Drug Administration (FDA) last year—and Gore Tag thoracic branch endoprosthesis (TBE), which recently acquired a new indication for use in aortic zones 0 and 1, dotted the programs of some of the regional vascular society meetings in September.
Data gathered from the Mayo Clinic in Rochester, Minnesota, and the University of Southern California Keck Medical Center in Los Angeles for a comparative analysis between fenestrated and branched endovascular aneurysm repair (F/BEVAR) using physician-modified endografts (PMEGs) and the off-the-shelf TAMBE device for complex
19 Advocacy Vascular surgeons descend on Washington, D.C.
RANDOMIZED DATA DEBUNKS WIDELY USED NEGATIVE PRESSURE WOUND THERAPY
By Jocelyn Hudson
“HOW DID AN INEFFECTIVE and costly intervention become routine care in the NHS [UK National Health Service]?”
Ian Chetter, MBChB, chair of surgery at Hull York Medical School, University of Hull in Hull, England, posed at the 39th European Society for Vascular Surgery (ESVS) annual meeting in Istanbul, Turkey (Sept. 23–26), following a presentation highlighting the SWHSI-2 trial results.
SWHSI-2—data from which were first shared at the 2024 Vascular Society of Great Britain and Ireland (VSGBI) annual scientific meeting and recently published in The Lancet suggested that negative pressure wound therapy (NPWT) should not be firstline treatment for open surgical wounds.
“Negative pressure doesn’t seem to have any benefit whatsoever.” This was Chetter’s key conclusion to be drawn from the “long-awaited” results of the SWHSI-2 trial in his initial presentation of the results at VSGBI 2024 meeting. For Chetter, the data underscore the severity of the clinical issue at hand, highlight a pressing need for research aimed at accelerating wound healing, and raise questions around how this technology—commonly used in the NHS—was accepted
See page 8
Medical Editor Malachi Sheahan III, MD
Associate Medical Editors
Bernadette Aulivola, MD | O. William Brown, MD | Elliot L. Chaikof, MD, PhD
| Carlo Dall’Olmo, MD | Alan M. Dietzek MD, RPVI, FACS | John F. Eidt, MD | Robert Fitridge, MD | Dennis R. Gable, MD | Linda Harris, MD | Krishna Jain, MD | Larry Kraiss, MD | Joann Lohr, MD
| James McKinsey, MD | Joseph Mills, MD | Erica L. Mitchell, MD, MEd, FACS
| Leila Mureebe, MD | Frank Pomposelli, MD | David Rigberg, MD | Clifford Sales, MD | Bhagwan Satiani, MD | Larry Scher, MD | Marc Schermerhorn, MD | Murray L. Shames, MD | Niten Singh, MD | Frank J. Veith, MD | Robert Eugene Zierler, MD
Resident/Fellow Editor
Saranya Sundaram, MD
Executive Director SVS
Kenneth M. Slaw, PhD
Managing Editor, SVS
Killian Meara
Senior Director for Public Affairs and Advocacy
Megan Marcinko Communications Specialist
Marlén Gomez
Published by BIBA News, which is a subsidiary of BIBA Medical Ltd.
Publisher Stephen Greenhalgh
Managing Editor Bryan Kay bryan@bibamedical.com
Editorial contribution Jocelyn Hudson, and Éva Malpass
Design Terry Hawes
Advertising Nicole Schmitz nicole@bibamedical.com
Letters to the editor
vascularspecialist@vascularsociety.org
BIBA Medical, Europe 526 Fulham Road, London SW6 5NR, United Kingdom
BIBA Medical, North America 155 North Wacker Drive – Suite 4250, Chicago, IL 60606, USA
The globalization of aortic innovation: A cautionary tale of U.S. regulatory overreach
By Shahab Toursavadkohi, MD
In 1954, Dr. Michael DeBakey transformed vascular surgery with a homemade Dacron graft sewn on his wife’s sewing machine. His spirit of innovation laid the foundation for decades of U.S.led advancement in aortic technology. However, recent trends suggest that this pioneering role is eroding, in large part due to the unintended consequences of regulatory tightening by the Food and Drug Administration (FDA).
The 2015 introduction of the custom medical device (CMD) and investigational device exemption (IDE) revision clause, which requires physician-sponsored IDEs for the use of physician-modified endografts (PMEGs), was intended to formalize oversight and ensure patient safety. But for many in the vascular surgery community, it has become a symbol of bureaucratic overreach that is obstructing progress. The U.S. regulatory burden now stands in stark contrast to the more permissive environments abroad, where innovation in complex endovascular aortic surgery has found fertile ground. To understand this shift, we conducted a scoping review—conducted with data gathering by research fellow Georges Jreij, MD, and medical student Jeffrey Lu, BS, and co-authored by Saurabh Gupta, MD, Khanjan Nagarsheth, MD, Mehrdad Ghoreishi, MD—of 5,197 articles addressing branched, fenestrated or physician-modified endografts, of which 263 met inclusion criteria. The majority (81%) were published after 2015, coinciding with the implementation of the CMD and IDE clause. Before 2015, the U.S. produced nearly 45% of these studies. After 2015, that share dropped to 24.3%, with China, Italy, Germany and Japan all increasing their output significantly. Interestingly, China went from a negligible presence to contributing nearly 14% of publications—an astonishing rise.
The shift is even more pronounced when comparing article types. Prior to 2015, 41% of U.S. publications were clinical trials; this fell to just 6% after 2015. Meanwhile, case reports and series rose to comprise 52% of post-2015 U.S. publications. For the rest of the world, this transition was even more dramatic, with case reports and series comprising 59% of studies post-2015. This increase in lower-tier evidence—while perhaps criticized by some—also reflects where the frontier of innovation is occurring: at the bedside, in real time, unencumbered by regulatory inertia.
Patient volume data echoed this trend. Before 2015, U.S.based publications represented 66% of all patients treated with advanced endovascular techniques. After 2015, the U.S.
Geographical distribution of publication ratios, pre- (A) and post-2015 (B) comparison
share dropped to 52%, while the rest of the world saw a fourfold increase in treated patients—nearly matching the U.S. total. Innovation, quite literally, has moved offshore. This is not just a matter of publication metrics or national pride. It affects patients and surgeons alike. Only about 10 U.S. sites currently have access to custom-made endografts under IDE protocols, despite the presence of more than 3,000 practicing vascular surgeons across 400 medical centers. The remaining majority are left waiting— not because of a lack of training or need, but because of systemic barriers that favor prolonged clinical trials over physician-led adaptability.
Meanwhile, many of the companies producing these devices are based in the U.S. but now conduct early feasibility studies overseas. The result is that U.S. vascular surgeons are increasingly reliant on global colleagues to define the future of their specialty. While large, structured U.S.-based trials continue to provide high-quality data, they do so at the cost of speed, accessibility, and realtime iteration.
China went from a negligible presence to contributing nearly 14% of publications—an astonishing rise
If we are to restore balance between regulation and innovation, one potential solution lies in expanding the role of real-world data collection through established registries. The Vascular Quality Initiative (VQI) and Society of Thoracic Surgeons (STS) databases could be leveraged to track advanced aortic procedures, providing post-market surveillance while allowing broader clinical access. This model has already proven successful in the case of transcarotid artery revascularization (TCAR), which received FDA clearance through VQI-based monitoring. A similar path could allow PMEGs and CMDs to break free of current constraints.
Dr. DeBakey didn’t wait for approval to innovate. He took the initiative, using available tools to solve urgent clinical problems. Today, many of us feel constrained from doing the same—not because we lack ideas or skill, but because we are fenced by red tape. If the U.S. hopes to reclaim its leadership in aortic innovation, we must embrace a more pragmatic, data-informed regulatory pathway— one that enables progress without compromising safety. Without change, the risk isn’t just falling behind; it’s becoming irrelevant.
SHAHAB TOURSAVADKOHI is an associate professor of surgery and co-director of the Aortic Center at the University of Maryland.
CLOSER TO THE GOAL: SHORING UP DATA BEHIND BREAKTHROUGH IMAGING TECHNOLOGY THAT PLOTS A RADIATION-FREE FUTURE IN NEW RCT
UMass
chief peers down the lens of an if-not radiation-free complex aortic procedural future, then one in which the methods of
today will look positively quaint. By Bryan Kay
“I SAY THIS A LOT,” SAYS ANDRES Schanzer, MD, “but I think there is a time within the next five or 10 years when we’ll be talking to medical students and they will say to us, kind of confused, ‘What do you mean you stepped on a pedal the entire time you were doing one of these cases.’”
The University of Massachusetts (UMass), Worcester, chief of vascular surgery is reflecting on the advance of imaging technologies designed to dramatically reduce exposure to radiation, particularly during lengthy complex aortic endovascular aneurysm repair procedures. Several modalities, loosely grouped together under the banner of “radiationfree,” have emerged in this space in recent years. The “radiation-free” tag represents a lofty goal. Or “a very high bar,” Schanzer says, explaining: “I think what we have all come to realize as we have explored these new technologies is that hopefully we can get closer and closer to that goal. But certainly, within the short term, we are not going to get to a complete radiationfree repair.”
Short of that high bar, significant strides forward have been made. And now, those advances have given way to a randomized controlled trial (RCT) designed to test one of these technologies. Playing on the radiation-free moniker, the RadFree unblinded, multicenter, international study places LumiGuide (Philips), powered by Fiber Optic RealShape (FORS), in a head-to-head with conventional X-ray in a bid to firmly establish that it requires less average fluoroscopy time. Several patients have already been randomized, with the
first receiving treatment using LumiGuide recently carried out by Darren Schneider, MD, at the University of Pennsylvania in Philadelphia. Schanzer is a principal investigator in this 11-site RCT. He has been on the radiation-busting trail for some time. His UMass team was involved in some of the earliest cases of FORS in the U.S., reporting a 75% decrease in fluoroscopy use while carrying out a fenestrated endovascular aneurysm repair (FEVAR) of a thoracoabdominal aortic aneurysm (TAAA). In the period since the technology first received Food and Drug Administration (FDA) approval in 2020, they have been at the center of studies probing its safety and effectiveness, Schanzer details. “We’ve had the opportunity to be involved in several institutional studies looking at our own data and some multicenter studies with other collaborators from the U.S. and around the world, and what we have learned in these early experiences is that use of LumiGuide seems to decrease radiation time, decrease radiation dose, and the hope is that by doing a randomized controlled trial we can definitively show whether or not there is a benefit associated with using this technology.”
The rationale is beyond question. The sheer length of a FEVAR or branched EVAR (BEVAR) can expose care teams to extensive amounts of radiation. Initial concerns around radiation exposure rightly focused on the patient, Schanzer continues. But, all things
considered, patients might expect to undergo one or perhaps two procedures. So thoughts soon turned to the fact that providers might take part in several over the course of any given week.
“If you think about it, it’s crazy that we’re standing right up against an image intensifier that is emitting radiation for procedures that can be several hours long, and we’re taking that radiation and exposing the entire care team to it, day in and day out,” says Schanzer. “So, this is a complete paradigm shift, and it has the potential to really be transformative if the results bear out and show that there is a significant reduction in radiation time and dose. Moreover, I’m sure that, as we continue to iterate on the generations of this technology, it will be able to be
“I think that we could potentially cut the dose of radiation more than in half by embracing technologies like this”
used for more and more steps of the procedure. It will be an adjunct to radiation use, but I think that we could potentially cut the dose of radiation more than in half by embracing technologies like this.” The UMass team has completed more than 100 cases
target vessels with LumiGuide’s FORS technology
using LumiGuide’s FORS technology. Schanzer believes the UMass data and that accumulated elsewhere in the U.S. and in Europe suggests wider use, but only an RCT like RadFree can provide the sort of robust evidence needed to do so. “The initial investigators that started using and testing LumiGuide have been working with Philips for several years now, and really pushing that we need level-1 data to support a larger, broad rollout of this technology,” Schanzer says.
Such technologies tackle some of the most radiation-intensive steps in complex aortic procedures. “There are certainly many technologies that have come along that have helped decrease the radiation necessary with the more modern, hybrid room setups,” Schanzer continues. “But even as we practice good radiation safety behavior, there still is a significant amount of radiation used for these complex procedures. Where we are with this technology is we can now take a lot of the radiation-intense steps and decrease the use of radiation, and eliminate it for several of these steps.” A case in point: cannulation of the vessels during FEVAR. “This is something that can be done entirely—safely and effectively—using LumiGuide,” he adds.
Meanwhile, Schanzer, who was recently elected SVS vice president, aims to continue driving forward with such research as he bids to help advance the cause of the Society membership at a time when “a lot of new diverse stakeholders are getting engaged with the SVS.”
Positive data show novel delayed-release diameter reduction technique in construction of PMEGs is viable
A NOVEL PHYSICIAN-MODIFIED ENDOGRAFT (PMEG) technique for the treatment of thoracoabdominal and complex abdominal aortic aneurysms (TAAA and AAA) involving delayed-release diameter reduction to aortic size and shape—allowing for sequential target vessel cannulation—is safe and effective, according to a new study.
Results from the 203-patient analysis of PMEG fenestrated endovascular aneurysm repairs (FEVARs)—carried out in a physician-sponsored investigational device exemption (PS-IDE) at Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, from 2017–2024—were presented at the 2025 annual meeting of the New England Society for Vascular Surgery (NESVS) in Providence, Rhode Island (Sept. 26–28). Delivering the data, Kirthi Bellamkonda, MD,
a vascular surgery resident at Dartmouth Hitchcock, set the scene: despite the emergence of commercial devices into the complex aortic aneurysm repair space, PMEG remains the predominant technology to treat these patients, and the traditional PMEG technique has changed little since its inception. Bellamkonda reported an average aneurysm diameter of 59.9mm among the cohort, with a distribution of 24% juxtarenal aneurysms, 46% pararenal aneurysms, 10% extent IV TAAAs and 18% extent II or III TAAAs. Technical success was 100%, with 30-day outcomes showing 2.5% mortality, 2% organ failure (of which half was renal failure), about 1% paraplegia and paraparesis, and 5% access site complications.
At one year, there were no cases of open conversion, stent fracture or migration, Bellamkonda added. Paraplegia and
paraparesis were found to be similar to the 30-day outcomes. One-year target vessel instability was 6.6%, of which 2% was component stenosis and 4.6% component occlusion. So why delayed-release diameter reduction, Bellamkonda pondered. “We reduce the number of simultaneous wires from four to one compared to the traditional technique, which reduces the risk of wire loss and re-cannulation, as well as the trauma to bridge vessels,” she said. “This allows us to work with a smaller contralateral sheath and improves intraoperative efficiency.” Given the continued role for PMEG in complex treatment, Bellamkonda said that the study group hopes to see the technique and design disseminate and help inform industry improvements in graft manufacturing. Bryan Kay
A series of images shows cannulation of
Andres Schanzer
FROM THE COVER EVOLVING EXPERIENCES OPEN UP CHANNELS
OF INQUIRY
continued from page 1
abdominal (AAAs) and thoracoabdominal aortic aneurysms (TAAAs) showed “comparable high technical success and optimal perioperative outcomes,” according to the study group.
Armin Tabiei, MD, a vascular surgery resident at the University of California Los Angeles (UCLA), presented findings from the study—covering procedures undertaken between 2015 and 2025— during the 2025 annual meeting of the Western Vascular Society (WVS) in Ojai, California (Sept. 14–17). Focused on a primary endpoint of freedom from target artery instability (TAI), Tabiei reported that among the 668 PMEG and 78 TAMBE patient groups, 77% of the former and 64% of the latter were estimated to be free of TAI at three years. “However, when only evaluating the renal target arteries, the freedom from instability was 89% for PMEG and 73% for TAMBE,” he said.
A majority of the patients were treated for TAAA, with a high rate of extent IV aneurysms. Early mortality occurred in 29 patients, all of whom were treated with a PMEG. Major adverse events occurred in 19% of the PMEG group and 17% of the TAMBE group.
Mean follow-up was 20 months in the PMEG group and 16 months in the TAMBE cohort. Three-year freedom from reintervention was 60% (PMEG) vs. 53% (TAMBE), while freedom from type I or III endoleak was 72% vs. 90%. “Freedom from aortic-related mortality was also similar, with rates of 99% in the TAMBE group and 94% in the PMEG group,” Tabiei added.
Overall survival was significantly lower in the PMEG group, with a three-year rate of 65% compared to 88% in the TAMBE group, which was “likely a reflection of more patients in the TAMBE group being treated under the clinical trial with more stringent inclusion criteria.”
Later in the same session, Zachary Rengel, MD, a vascular surgery resident from the Keck Medical Center, took a look at renal artery outcomes at the vessel level, comparing TAMBE and PMEG repairs, seeking to identify risk factors for TAI that could help guide patient selection. Covering procedures from 2015–2025 carried out at the same two aortic centers, Mayo and USC, Rengel told WVS that 633 patients underwent PMEG and 88 TAMBE. “This encompassed 1,339 renal arteries split almost evenly between the right and left,” he said. At five years, freedom from TAI was significantly higher in PMEG patients at 89.5% compared to 82.7% in those treated with TAMBE. “Right renal arteries had worse performance with TAMBE—77.9% at two years compared to 91.3%,” Rengel continued. “Left renal arteries were comparable, with a significant difference seen between PMEG and TAMBE.”
In a subgroup analysis by aneurysm extent, “we saw that this difference in target vessel instability was driven by the pararenal aneurysms. Twoyear freedom from target vessel instability was nearly 94% for PMEG but only 76% for TAMBE,” Rengel said. “In TAAAs, there was no significant difference: 93.5% for PMEG vs. 89.6% for TAMBE.”
Comparing bridging stent types in patients who had a single type, there was no significant difference in freedom from TAI between those used—VBX and iCast stents.
“We observed that primary patency in part drove the target vessel instability findings,” Rengel explained. “At five years, PMEG maintained to 94% patency versus 83% for TAMBE. Again, we saw that patients with pararenal aneurysms seemed to drive these findings with the two-year primary patency difference of almost 20%, although TAAAs saw a modest difference.
patients enrolled in the TAMBE clinical trial from June 2021 to May 2024 and a further nine treated after device approval in June 2024. While the indication for all trial patients was aneurysmal and elective, the post-trial group included one emergent rupture and two type A aortic dissections with pararenal aneurysms, Rushing told EVS 2025. Among the post-trial patients, five would not have qualified for the clinical trial.
A higher percentage of post-trial patients had previous aortic coverage and a larger descending aorta compared to trial patients, she continued. “The posttrial patients had a longer length of stay and higher rates of transient spinal cord ischemia,” she said. “Both cohorts had no type I endoleaks, while one post-trial patient had a type III endoleak.”
“These findings suggest that TAMBE renal branches have higher target vessel instability compared to PMEG”
ZACHARY RENGEL
“When looking at laterality for primary patency, we saw again that the right renal artery had a more significant difference in comparison to the left, with five-year primary patency being 93% in PMEG and 80% in TAMBE. We did not observe any differences between PMEG and TAMBE in freedom from branch endoleaks, with TAMBE actually performing slightly better at 98.2% vs. 93.9%. Freedom from reintervention also favored PMEG at five years.”
Cox proportional hazard modeling showed that TAMBE usage and bridging stent diameter were independent risk factors of TAI, Rengel added. “These findings suggest that TAMBE renal branches have higher target vessel instability compared to PMEG, driven by the loss of primary patency and branch reintervention at the right renal artery, and is more pronounced in patients with pararenal aneurysms.”
At the 2025 Eastern Vascular Society (EVS) annual meeting in Nashville, Tennessee (Sept. 4–7), Amanda Rushing, MD, a vascular surgery resident at Mount Sinai in New York, reported on her institution’s experience with the TAMBE device.
Rushing and colleagues looked at eight
There were no mortalities, strokes or myocardial infarctions (MIs) at 30 or 60 days among trial patients, whereas there was one MI within 30 days in the post-trial group, Rushing added.
“When looking at TAMBE in our postmarket analysis, patients treated outside the guidelines of the clinical trial had high technical success and comparable outcomes to those performed in the clinical trial,” she concluded.
Also at EVS 2025, Grayson Pitcher, MD, an assistant professor of vascular surgery at the University of Rochester in Rochester, New York, reported on lessons learned from a multi-institution case series of TAMBE cases involving wire wrapping of the celiac and superior mesenteric arteries. Wire wrapping most commonly occurs with celiac and superior mesenteric artery catheterization during interaction with the preloaded guidewires, Pitcher said, urging colleagues to be aware of this phenomenon.
“TAMBE has shown promising results, but something we have found is that stent wrapping can occur and it is important that everyone really be aware of this challenge,” Pitcher said, adding that the cases to which he referred highlighted the importance of using non-contrast conebeam computed tomography.
Meanwhile, new data emerged at EVS 2025 on the TBE, including patients receiving treatment in aortic zones 0 and 1, the expanded indication for which was approved by the FDA in June. Rushing, of Mount Sinai, delivered an institutional experience involving 32 TBE procedures between October 2022 and March 2025.
“TBE is the first off-the-shelf singlebranch endoprosthesis for the zone 0, 1 and 2,” she told EVS. “Originally for zone 2 alone, this device has recent FDA approval for zone 0 and 1, and few studies have investigated the use of TBE in these zones, and even fewer its use in concomitant procedures, specifically type B aortic dissections [TBAD].”
The retrospective observational review included 25% with a zone 0 or zone 1 repair. Of the three patients who had a zone 0 repair, all involved chronic TBAD. Of five patients who had a zone 1 repair, three were aneurysmal in nature and two were chronic TBAD. Overall, a majority of the repairs (69%) were for TBAD, with the remaining 31% for aneurysm alone.
“For zone 0, all three of these patients underwent a right-carotid-to-leftsubclavian bypass, and then transposing the left carotid onto that bypass,” Rushing explained. “In our remaining subset of zone 1 patients, three of the five underwent a left-carotid-to-left-subclavian transposition. This allowed us to cover the origin of the left common carotid artery with our portal into the left subclavian artery, and gaining that zone 1 access just distal to the innominate take off.
“We had a very high percentage of rightsided aortas in this patient population. Two of the 32 patients had right-sided arches,” Rushing continued. “One of these patients underwent a left-carotid-to-leftsubclavian bypass with a TBE portal into the right subclavian artery. The other right-sided patient had a bilateral carotidto-subclavian bypass with the TBE portal into the right common carotid artery. Among our other anatomic anomalies, one patient had aberrant right subclavian artery.”
Intraoperative and 30-day complications included three closure device failures, one patient had a common iliac rupture, two had unplanned partial coverage of a cerebral vessel, and one patient had a radial artery pseudoaneurysm, Rushing said.
Further, there were no patients with transient spinal cord ischemia, one patient had a type III endoleak and all stents were patent at 30-day follow-up. There was one stroke within 30 days and one mortality within 120 days resulting from respiratory failure and subsequent cardiac arrest.
“Of the patients that had follow-up within one to two years, there was no mortality, stroke or MI within this patient subset,” Rushing added.
RevCore™ Thrombectomy Catheter
The First Mechanical Thrombectomy Device for Venous Stent Thrombosis
Indications For Use:
The RevCore Thrombectomy Catheter is indicated for (1) The non-surgical removal of thrombi and emboli from blood vessels (2) Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature. Refer to IFU for complete Indications for Use, contraindications, warnings, and precautions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
When to re-intervene: Stent surveillance and the effective use of RevCore mechanical thrombectomy to clear in-stent thrombosis
How a finely tuned stent surveillance program plays a crucial role in raising the alarm of worsening symptoms in DVT patients and identifies those who might require reintervention with mechanical thrombectomy.
For Jake Hemingway, MD, the key to his practice of treating patients with deep vein thrombosis (DVT) and the long-term effects in those who develop post-thrombotic syndrome (PTS) is not simply a robust, fastidious stent surveillance program, but something he thinks of as a wider DVT surveillance program.
The scope of the patient population is not insignificant, he says. “In a lot of hospital systems, patients with acute iliofemoral DVT get treated. People with superficial disease or varicose veins get treated. But there is a huge proportion of patients in between who have PTS or chronic sequelae of DVT that just aren’t really owned by anyone.”
Hemingway, an assistant professor of vascular surgery at the University of Washington (UW) in Seattle, is guided by a philosophy that includes a commitment to lifelong management and a program designed to capture patients with chronic venous disease of all segments who might otherwise fall through the cracks. He sees patients across the spectrum, but one population stands out: PTS patients who have undergone treatment at an outside facility and have had an early in-stent thrombosis, or those who have received a prior intervention that was ultimately unsuccessful. What unites them is the fact these patients tend to be younger and require long-term care.
six-, and 12-month timepoints, then yearly thereafter. The surveillance program means issues that arise are picked up “much earlier on,” he adds.
When to re-intervene
Hemingway’s threshold for re-intervention is dependent on a couple of factors.
“If a patient has a really challenging reconstruction and has a lot of inflow disease, and I think there might be something I can improve upon, I will look to go in,” Hemingway explains. “Or: if a patient comes in and they are outlining that they are not that symptomatic, but they missed a few days of anticoagulation, and now they have some in-stent thrombosis with an area that looks to be quite narrow and the flow is in continuous wave forms.”
He points to the classic case in point—in the setting of an inferior vena cava (IVC) and bilateral iliofemoral reconstruction. In these cases, the key to success is a combination of listening to the patient and treating recurrent symptoms.
“The reality is that nothing is permanent in vascular, so you really do have to deal with problems as they come up,” says Hemingway. So it stands to reason that, after placing a venous stent, “you should see that patient for life.” To that end, he continues, “it’s always easier to take care of a problem before it becomes a serious issue rather than dealing with a chronic occlusion many years later. Tied into that is that you need to understand what you’re doing to patients over the long term.”
Hemingway’s stent surveillance program is standardized. Follow-up appointments are scheduled at the same time as the index procedure. Patients receive an initial duplex ultrasound on postoperative day one. They are then followed at the twoto-four-week mark, after which—if their imaging is clear—they return at the three-,
weeks, and now, over the last four weeks, it has stagnated or maybe even grown in size,” he explains. Then there are the patients with stents that appear to be clear but symptoms are recurring. “That’s when I start looking at superficial disease. I start to think about reflux, and other pathologies that might be contributing.”
All of which raises the question of treatment modality, and which cases point to which method of re-intervention. In most scenarios, Hemingway outlines, the most effective modality to remove in-stent thrombosis is mechanical thrombectomy with the RevCore thrombectomy catheter (Stryker/ Inari)—except in the setting of couple-ofweeks-old acute stent thrombosis.
“Unless I have a patient where I put a stent in, I have imaging that shows that it is open, and I have imaging that shows that it
To that end, the asymptomatic patient with a widely open stent will continue to be monitored under surveillance. But what about the patient who reports with either a 50%-or-more narrowing with associated flow abnormality like continuous waveforms peripherally? “We know there is a drop in the volume of flow rate in comparison to their postop day one duplex, especially if that is seen either at the two-week or three-month mark,” Hemingway says. “That’s when I’m much more aggressive about going in because I think you have your best chance of fixing things. With an early stent thrombosis, I will often have a lower threshold to intervene on a patient, especially if there is a narrowing that appears to be fairly significant and associated with more peripheral hemodynamic effects.”
Hemingway also re-intervenes when patients show evidence of stenosis and recurrent symptoms, whether mild or severe. “You see a change in the duplex, you notice some thrombus layering and continuous waveforms, with the patient noticing that their wound was healing well for two
associated iliofemoral thrombosis. The IVC and common iliac vein (CIV) stents were thrombosed.
“Both sides had gone down,” Hemingway explains. “One was thrombosed all the way through, the other had a wisp of flow going through it. I took the patient for a venogram and tried aspiration without success, so then tried the RevCore. What we got out was all white, rubberish, fibrotic material. This is someone in whom, had I opted for aspiration thrombectomy, I would have had to reline the whole stent reconstruction. We were able to clean out the stent and send the patient home without any new stents being placed.”
Post-intervention, the patient was noted to have brisk flow on venogram, no thrombus layering on intravascular ultrasound (IVUS), and no further stenting was
Sequential images demonstrate treatment of in-stent thrombosis using the RevCore catheter, showing complete thrombus removal and restoration of luminal patency 1 2 3
“I took the patient for a venogram and tried aspiration without success, so then tried the RevCore. What we got out was all white, rubberish, fibrotic material”
JAKE HEMINGWAY
is occluded and I can definitively say that it is a two-week-old occlusion, then I’m generally likely to reach for the mechanical option because I think it does better with that subacute thrombus,” he says.
RevCore mechanical thrombectomy in action
Hemingway recalls a classic case using the RevCore Thrombectomy Catheter that underlines why the modality is his go-to in these types of scenarios.
The patient was a 35-year-old male who presented with worsening back pain, leg swelling and edema that on imaging appeared to point to an acute DVT. Several years prior, he had undergone thrombectomy, IVC stenting and a bilateral iliocaval reconstruction for chronic IVC occlusion and
required. Now 18-months post-procedure, the patient has sustained full patency and complete symptom resolution.
Decisions around intervention are influenced by timing, Hemingway points out. “If a patient has an occluded stent for six months or longer, I think that the results are less predictable and it is a little harder to know whether you’re going to get great thrombus clearance,” he says. “If it is a case of less than six months and definitely less than three months, my experience has been that RevCore has worked very well for clearing out in-stent thrombosis. If you are patient, and really work the areas, you use the device correctly and really grind away at that thrombus layer by layer, you will get it cleared out. Once it gets to be rock hard or associated with calcification, there’s just some pathology you can’t pull out of there.”
This is an article sponsored by Inari Medical. The HCPs sharing their views and opinions here express their experience with Inari Medical devices. The HCPs’ opinions of these devices were formed independently of Inari Medical and may not represent every experience or outcome with the devices.
Indications For Use:
The RevCore thrombectomy catheter is indicated for (1) the non-surgical removal of thrombi and emboli from blood vessels and (2) injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel. The RevCore thrombectomy catheter is intended for use in the peripheral vasculature. Review complete Instructions for Use, Indications for Use, Warnings, Precautions, Possible Adverse Effects and Contraindications prior to use of the product.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. For all non-Inari products, please refer to complete manufacturer Instructions for Use/Intended Purpose. All copyrights and trademarks are the property of their respective owners.
PRO-2406-USA-EN-v1
Jake Hemingway
Iliac branch device
‘equally effective’ in both IDE and registry studies, new data show
By Jocelyn Hudson
RESEARCHERS HAVE REPORTED COMPARABLE five-year outcomes of the Gore Excluder iliac branch endoprosthesis (IBE; Gore) in both the investigational device exemption (IDE) and GREAT registry studies of the device.
Meghan Barber, MD, a vascular surgery fellow at the University of Chicago, shared this main finding from a new comparative study at the 49th annual meeting of the Midwestern Vascular Surgical Society (MVSS) in Cincinnati, Ohio (Sept. 18–20).
Barber began by sharing the researchers’ hypothesis that there would be no difference in outcomes between the IDE study of the IBE device and the IBE component of the GREAT registry, representing “ideal” and “real-world” scenarios, respectively. In order to test their hypothesis, the researchers compared the five-year outcomes of patients included in both the IDE study and the GREAT registry in the period 2013–2016.
FROM THE COVER RANDOMIZED DATA DEBUNKS WIDELY USED NEGATIVE PRESSURE WOUND THERAPY
continued from page 1
into clinical practice without the robust evidence to back it.
Providing context to the trial at the UK meeting, co-investigator Catherine Arundel, MD, from York Trials Unit at the University of York in York, England, first noted the “common” nature of secondary wounds healing by secondary intention (SWHSI) and the “prolonged and complex” nature of their healing. Arundel also underlined the costly nature of treatment, “particularly considering that the use of complex, expensive treatments such as [NPWT] has been and continues to be increasing.”
Against this backdrop, SWHSI-2 was initiated by Chetter, Arundel and colleagues and funded by National Institute for Health and Care Research funding. This was a pragmatic, multicenter, two-arm, parallel-group randomized controlled trial designed to assess NPWT versus usual care in patients with open surgical wounds. The primary outcome was wound healing and time to wound healing. Across 28 UK sites, 686 patients were enrolled, with 349 allocated to the negative pressure intervention group and 337 to usual care. Chetter then provided an overview of patient characteristics, noting that 75% of
porting that the only differences identified between the two groups were that more patients were followed out to five years in the GREAT registry and that there was “slightly higher” all-cause mortality in GREAT. “Otherwise,” she says, “there was no difference between the two sets of patients.”
Barber comments that these results are “really good” for the IBE device. She notes: “The good outcomes we were able to demonstrate in the controlled setting of an IDE trial translated very well to the patients that were in the GREAT registry.”
Senior author Ross Milner, MD, chief of vascular surgery at the University of Chicago, explains that the IBE component of GREAT comprises the final group of patients included in the registry. He explains: “When the IBE device got FDA [Food and Drug Administration] approval, it was actually fairly close to the time that we had enrolled the 5,000 patients we were looking for, so we actually have more patients in the registry than the IDE study.” Milner notes that there were roughly 60 patients included in the IDE study compared to around 90 in the IBE component of GREAT.
those who perform endovascular aneurysm repair (EVAR) with an IBE can be “confident” their outcomes will mimic those seen in the setting of a clinical trial.
From a strategy standpoint, Milner continues, “most peo ple would prefer to use an internal iliac branch when possible, for preservation.” He does stress, however, that both the IDE study and IBE portion of GREAT are U.S. centric, which “obviously makes it a little bit harder to extrapolate to the rest of the world.”
Milner says that the ability to use an iliac branch device for internal iliac artery preservation was “equally effective” in both the IDE study and the GREAT registry. He adds that
“I don’t think that much has changed in the last five years at least, but in the next 10 years that may be a different story”
MEGHAN BARBER
the trial cohort were men, the majority of whom were white and had diabetes. He added that 90% of patients were vascular patients. “Although we tried to recruit across the different surgical specialties,” said Chetter, “this ended up being a vascular surgical, diabetic foot wound trial.”
Regarding wound characteristics, Chetter shared that the wounds included in the trial were large—26cm2 on average—with the majority on either the foot or the leg.
Sharing the results of SWHSI-2 for the first time at VSASM 2024, Chetter reported that 42% of patients had unhealed wounds at 12 months, a result which “shocked” him. “Importantly,” he continued,” there was no difference in the number of healed wounds between patients randomised to negative pressure or usual care.”
Chetter added that the median time to wound healing was 187 days (NPWT)/195 (standard dressings), or six months, and that there was no difference between negative pressure and usual care. “There’s no evidence that negative pressure accelerates healing in these patients,” the presenter told the VSASM audience, going on to state that the primary result was consistent throughout various subgroup analyses.
The researchers also looked at secondary outcomes, finding high rates of hospital readmission, reoperation, and wound infection, as well as a high number of patients receiving antibiotics for their surgical wound infections, with no statistically significant difference between the two groups. “Negative pressure doesn’t reduce wound infection, doesn’t reduce your risk of reoperation, and doesn’t reduce your risk of requiring antibiotics,” Chetter said.
Furthermore, on the topic of secondary
On the next steps for GREAT, Milner notes that there are now long-term follow-up data available, referencing 10-year results on some of the patients treated with standard EVAR using the Excluder ab dominal aortic aneurysm (AAA) endoprosthesis (Gore). “That’s the predominant patient population in the registry,” he says, noting that almost 3,300 patients out of 5,000 in GREAT underwent EVAR with the Excluder. Milner notes that one of the limitations of GREAT, however, is the lack of core-lab imaging. “We’re completely dependent on the sites for recognition of prob lems,” he says. In order to address this, Milner explains that Gore has now established the TOGETHER registry, which will feature core-lab imaging and a “more in-depth under standing of patient selection.”
“The goal is to collect 150 IBE patients,” Milner shares, highlighting the main goal of TOGETHER as being to assess branch technology, with the Gore IBE set to be a “big com ponent” of the study. The pair also consider the Gore IBE as part of the wider treatment landscape. While acknowledging that changes in how patients are treated are inevitable, Bar ber emphasizes that the IBE is “still a fairly unique device.” She remarks: “I don’t think that much has changed in the last five years at least, but in the next 10 years that may be a different story.”
outcomes, Chetter underlined that 10% of patients ended up with an amputation and 10% of patients died.
Quality of life was also measured. “With both treatments,” Chetter reported, “the scores improved—so wound healing improved, and pain improved with both treatments over time—but there’s no statistically significant difference between the two groups. So, negative pressure doesn’t improve wound pain and doesn’t improve your quality of life related to the wound.”
Finally, Arundel shared the results of a cost-effectiveness analysis. “Within the trial,” she summarized, “we can say that negative pressure was more costly, but not more effective than usual care.”
The researchers also considered the longer-term cost-effectiveness of negative pressure, employing a decision analytic model that allowed the team to use both evidence from the trial and external evidence. “There are very small gains in quality-adjusted life years over a longerterm model,” Arundel shared with VSASM. “There were lower healthcare costs for negative pressure compared to usual care, but higher intervention costs, and the incremental costs are therefore higher for negative pressure, but not significantly.”
“There was no gain in terms of quality of life, and no real gain in terms of cost either,” Arundel concluded at this point during the dedicated SWHSI-2 trial session.
‘A chronic, disabling problem’ Following the presentation of these firsttime results, Chetter shared his key takehome messages.
“These wounds are a chronic, disabling problem,” the presenter stressed, citing
again the proportion of wounds in the trial that did not heal being “much higher” than he expected and the length of time it took for those wounds that did heal being “much longer” than anticipated.
Chetter continued that the indications for negative pressure are “minimal”. It “doesn’t accelerate healing, doesn’t improve your quality of life, and doesn’t reduce those secondary outcome measures that we looked at,” he listed. In addition, the presenter reiterated that negative pressure does not reduce a patient’s chance of their wound getting an infection, does not reduce their chance of needing another operation or being readmitted to hospital, and does not reduce their chance of needing antibiotics. Chetter also referenced again the “scary” amputation and mortality rates of 10% among the patients included in the trial.
Here, Chetter queried how the SWHSI-2 findings might impact his clinical decisionmaking moving forward. “If I was faced with a patient […] and I could predict that that patient would be in the 40% that didn’t heal or be in the 10% that ended up with an amputation, anyway, would we together— me and the patient—make a different decision about how we manage that foot problem?” he asked.
Closing his presentation, Chetter restated the severity of the problem at the centre of the SWHSI-2 trial. “These wounds are horrendous,” he stressed. “They severely affect our patients.” As a result, Chetter’s forward-looking message was clear: “We need to continue research to try and find a way to accelerate wound healing. Patients are desperate to get these wounds to heal and the quicker we can help them heal these wounds, the better.”
Meghan Barber
How likely are your surgical patients to have disruptive bleeding?
‘ASK NOT WHAT VASCULAR SURGERY CAN DO FOR YOU… ASK WHAT IT CAN DO TO YOU’
By Bryan Kay
DURING HIS OWN RECENT PRESIDENTIAL ADDRESS on home turf, Patrick Muck, MD, invoked immortable words from the inaugural address of President John F. Kennedy to make a very serious point about radiation safety in vascular care: “Ask not what vascular surgery can do for you… ask what it can do to you.”
Muck said that with the rise in endovascular intervention over open surgery, and procedures becoming longer and more complex, the foundational principle in radiation protection of ALARA, or As Low As Reasonably Achievable, should be placed firmly into vascular surgery’s focus.
“It is aimed at minimizing exposure to ionizing radiation while considering economic, technical and social factors,” the 2024–25 Midwestern Vascular Surgery Society (MVSS) president and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio, told those gathered in the Queen City for MVSS 2025 (Sept. 18–20). “It emphasizes optimization: justifying any radiation use and keeping doses as low as practical without a strict zero-exposure goal.” Yet its application, interpretation and associated dose limits have evolved, and “while the core principle hasn’t been overhauled, supporting elements like dose limits and implementation guidance has shifted.”
With little change over the decades, he said, are governing bodies suitably adapting to radiation protection technology now available to mitigate exposure?
“We’re doing more and more minimally invasively, whether it be aneurysm, peripheral arterial, TCAR [transcarotid artery revascularization], IVC [inferior vena cava] filter, venous and dialysis procedures,” he tells Vascular Specialist after the address. “Because of that, we’re getting longer and longer cases and more and more exposure to radiation. We know what radiation can do to us, but do we discuss this topic enough and the mitigation systems that are now out there?”
Muck referred to several emerging barrier protection technologies during his address, among them EggNest radiation protection, the Protego radiation protection shield and the Radiaction shield. Speaking to Vascular Specialist, he focused on one which was recently introduced at his center: the Rampart Guardian system, a ceiling-mounted or mobile radiation shield, aimed at providing barrier protection. “I showed a couple of cases we’ve done, one an endovascular aneurysm repair [EVAR] and the other bilateral iliac stent placement,” he says. “For the EVAR, we used the Rampart Guardian system and I showed how we received only 0.2mrem. The next day, when we did the bilateral iliac stents, we used traditional shields and personal lead protection and had 3mrem, 15 times the radiation, this is the same old personal protection and shielding we have been using for decades.”
The time is now to address radiation mitigation and consider bringing in systems like those from EggNest and Rampart Guardian, Muck added. “I believe we’re just at the infancy with barrier protection.”
IT “TAKES A village” to build a community like the one that the Eastern Vascular Society (EVS) has grown into, outgoing president
Brajesh K. Lal, MD, told the EVS annual meeting in Nashville, Tennessee (Sept. 4–7). Lal was delivering the 2025 presidential address on building on the society for the 21st century.
He told those gathered that the sort of “frontier spirit, camaraderie and environment for mentorship” he saw early encouraging young people to choose vascular as a career is “so integral to the personality of this meeting. I am very happy to say that this focus on mentorship is just as strong today as it was when I joined,” he added, revealing how the society had just passed the 1,000-member mark.—Bryan Kay
Ross Milner (left) with Patrick Muck
Brajesh K. Lal
The Surgical Doppler You Can Rely On–Now Easier to Use
RELIABLE
It’s the next generation of our Trans-Q-taneous Intraoperative (TQI) Doppler System, combining the reliability and cost effectiveness of the original TQI Doppler with new, user-friendly features.
Increased Portability
In addition to its smaller size, the TQI 2.0 Doppler now features an IV pole mount and a handle for easy transport.
Greater Control
The modern design of the TQI 2.0 Doppler allows for a foot pedal for increased control from the surgical field.
Improved Sound
The TQI 2.0 Doppler System is optimized for clear audio signals for both intraoperative and transcutaneous use.
VTI’s single-use surgical Doppler probes provide a higher degree of performance reliability since probe failure due to reprocessing is eliminated. You’ll reach for your Doppler with confidence!
COST-EFFECTIVE
Single-use surgical Doppler probes eliminate reprocessing costs as well as the hidden expenses associated with the malfunctioning of reusable probes such as lost OR time.
Visit our TQI product page on our website.
TADV without venous branch coiling still yields strong limb salvage rates among ‘no-option’ CLTI patients
By Killian Meara
TRANSCATHETER ARTERIALIZATION OF DEEP veins (TADV) done without the coiling of venous outflow branches achieved sufficient distal perfusion after three months among “no-option” chronic limb-threatening ischemia (CLTI) patients, according to results from a study published in the Journal of Vascular Surgery (JVS).
TADV, also known as deep vein arterialization (DVA), is an emerging option for CLTI patients who can’t receive traditional revascularization techniques. Although the coiling of venous outflow branches is a common adjunct procedure to TADV, a lack of data has brought into question how critical coiling off venous outflow branches really is.
To investigate this question, researchers from Massachusetts General Hospital in Boston conducted a retrospective
chart review on a cohort of “no-option” CLTI patients who had TADV performed using the LimFlow system (Stryker/ Inari Medical) between 2020 and 2024. Flow volumes were assessed at one and three months via ultrasound measurements and clinical outcomes were evaluated at one year.
“The point of this particular study was we wanted to look at the coiling of the branches to see how important it is to actually go and coil off these branches in order to ensure that the DVA actually matures,” Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital and an author on the study, told Vascular Specialist. “What we found is that for a number of these branches, frankly, the majority of them, you do not have to coil off the branches and the circuit matures anyway.”
Data showed the patients who underwent TADV without venous branch coiling had an 87% limb salvage rate one year after the procedure. The patients also maintained a flow rate of 179.0mL/min for three months at midstent, as well as a median decrease of 123mL/min at one month.
Dua said because TADV without venous branch coiling is a “one and done” procedure, it is more accessible to vascular teams—particularly those in lower resource settings. It also could accelerate use in the community, decrease costs and make patients more likely to have it done. “By decreasing the burden of the procedure, both on the provider and on the patient, you make it significantly more accessible across the board,” said Dua.
“Being able to ensure that pretty much anybody with wire and catheter skills can do this procedure is important”
SUBOPTIMAL GSV NON-CONTRAST MRI OUTPERFORMS DSA IN DETECTING BELOW-KNEE ARTERIES IN CLTI PATIENTS
“IMAGING PATIENTS WITH below-the-knee CLTI [chronic limbthreatening ischemia] is challenging,” said Alexander Crichton, MBChB, a postdoctoral researcher at Houston Methodist Hospital in Houston, Texas, during the 39th European Society for Vascular Surgery (ESVS) annual meeting (Sept. 23–26) in Istanbul, Turkey, as he presented new data on behalf of the frontier-pushing lab of vascular surgeonscientist Trisha Roy, MD, at Houston Methodist. Crichton was citing the rise in diabetes and end-stage renal failure as two of the key reasons behind this, noting both cause calcified arterial disease that can “significantly” affect computed tomography (CT) and ultrasound imaging, and asked the audience: “Is digital subtraction angiography—our gold standard of current imaging—showing us what we need to see? Is it similarly affected by this calcium?”
Regarding the available literature on the topic, the presenter referenced a study
from the 1990s showing that non-contrast MRI could identify more patent vessel segments than DSA. He noted that this finding changed the researchers’ management of patients in 17% of cases. The problem was, however, that the technique was slow and marred by imaging artifacts. “It never really caught on,” Crichton remarked.
However, performing TADV without venous branch coiling does come with some risks. Dua said that by not coiling off some branches in the beginning that might be stealing blood, the TADV will not be able to strengthen. This could make the whole operation unsuccessful due to a lack of blood flow, resulting in an unproperly healed wound.
“It is important to ensure that if there are stealing branches that are significant, that they are managed,” said Dua. “It’s also important to recognize it’s not a hammer and everything is not a nail. You don’t have to do every single branch because you can get out of control that way. Being very careful and methodical about what you pick and when is key to the success of the procedure.”
During a session at the 2025 Vascular Annual Meeting (VAM) in New Orleans in June, Dua presented data showing patients who underwent TADV in the PROMISE trials had a limb salvage rate of 82.2%, compared to 51.3% of those in the CLariTI trial.
Additional real-world outcomes data supporting TADV were also recently revealed at the 2025 annual meeting of the Eastern Vascular Society (EVS) in September.
“The next question is how do we make it better,” said Dua. “We know it works; patients are keeping their legs. We have to make it easy for providers to be able to do. Because unlike cancer, where a patient can get a bad cancer and they can travel to [MD Anderson Cancer Center] or they can go to [Memorial Sloan Kettering Cancer Center], that’s not the case for peripheral arterial disease [PAD] and CLTI. In these patients, if they don’t get something locally, they are going to lose their leg. Being able to ensure that pretty much anybody with wire and catheter skills can do this procedure is important. That is what we all believe—that it’s something that can be done.”
study, the researchers compared these patients’ QISS MRIs to their DSAs across 14 vessel segments.
He stated that clinicians now commonly use contrast-enhanced MRI. “But in 2025, do we need to?” he asked, citing newer, non-contrast MRI techniques, such as QISS MRI, that are fast, less affected by artifacts and “give a fantastic image.”
At Houston Methodist, Crichton shared, clinicians offer patients who require an MRI of their lower limbs a QISS MRI followed by a contrast MRI. In the present
The primary outcome of the study was to assess whether QISS MRI could identify more patent vessel segments than DSA, with the secondary outcome being the effect of QISS MRI versus DSA on disease severity scores, namely Trans-Atlantic Inter-Society Consensus (TASC) and Global Limb Anatomic Staging System (GLASS) scores. In total, the researchers compared QISS MRI to DSA across 752 vessel segments in 56 patients. Crichton reported that the median time from QISS MRI to DSA was short, at around four days, and that the number of patent vessel segments on QISS MRI was an average of 10% higher than that on DSA, which he detailed was a statistically significant difference.
In addition, Crichton revealed that the difference in the number of visible vessels on QISS MRI compared to DSA became more pronounced the further down the limb the imaging was used. He cited a statistically significant difference of over 30% at the level of the dorsalis pedis.
The presenter also noted a “knock-on effect” on both TASC and infrapopliteal GLASS scores. “The mean TASC score and the mean infrapopliteal GLASS score were significantly downgraded when we used QISS MRI to evaluate these arteries,” he said. “This is really important, because this is our language to classify disease severity. It’s what we’ve used in the most recent SWEDEPAD trial.”
To demonstrate the clinical implications of the researchers’ finding, Crichton cited a case example involving the search for a patent dorsalis pedis artery that did not show on DSA, but did on QISS MRI, with the QISS MRI also revealing a patent distal anterior tibial artery. “This changes how we manage this patient. I believe that this gives you more options to treat it,” he commented.
Sharing his take-home messages, Crichton summarized that QISS MRI identifies more arterial segments than DSA, with the difference between the two imaging modalities becoming increasingly significant the further down the limb they are used. He reiterated that QISS MRI also affects both TASC and infrapopliteal GLASS scoring, downgrading both. “But most importantly,” he said in closing, “I truly believe that this could change how we manage our patients. This is easy to integrate into our practice, and I think we could use it a lot more.”—Jocelyn Hudson
Alexander Crichton
Anahita Dua
Whatever is on your schedule today...
Getinge has a graft for that
Every day, you perform a wide variety of complex vascular procedures. You need a variety of grafts. Getinge delivers a comprehensive portfolio of vascular grafts and patches in a range of materials and coatings—from hybrid and ePTFE to heparin bonded and collagen. Backed by evidence, a long history of use and continued investment and innovation in vascular graft technology, Getinge is the only graft portfolio you need.
Solutions. Selection. Support.
A global concern: WFVS seeks to level up vascular education in every corner of the world
WFVS secretary general details how the organization has evolved in recent years, seeing gains in representation and access to education. By
Bryan Kay
IN THE STEW OF NATIONAL AND REGIONAL vascular societies that dot the globe, the World Federation of Vascular Societies (WFVS) might get somewhat overlooked. You might be peripherally aware of the group, you might have heard the current secretary general talk about it at a podium somewhere in the not-too-distant past, but you might not be too sure what it is and what it does. Those are maladies Palma Shaw, MD, the WFVS secretary general in question, wants to remedy.
“The whole mantra of the WFVS is the haves help the have nots,” Shaw tells Vascular Specialist she gears up to attend the latest WFVS symposium in South Africa. “We’re here to pool our resources together and we’re committed to that. We’ve spent a lot of time trying to re-establish the federation as an impactful entity. We’ve put on a lot of different sessions to increase the federation’s visibility, and we have really worked to bring together resources that are accessible.”
A quick refresher on its reason for being: The WFVS is an umbrella organization that unites societies across the globe; a collaborative forum to advance vascular science, education and patient care worldwide; and a network to share expertise and establish global standards of care. In 2021, the federation was revamped with bylaw updates, a new website, and the SVS taking over day-to-day management.
Shaw says those founding WFVS goals have seen some significant advances in recent times. One of the most prominent: the Global Training Initiative is now established with the aim of bringing together trainees and young surgeons from across the world in accessible programming. “We have representatives from each member society who come to -
VASCULAR PRACTICE
‘THE PATIENT IS THERE TO SEE ME AND MY FACE’: MAKING SHARED DECISION-MAKING CENTRAL TO VASCULAR CARE
MATTHEW CORRIERE, MD, believes a major shift is needed in how clinicians communicate and make decisions with their patients. During the 2025 distinguished address given at the New England Society for Vascular Surgery (NESVS) annual meeting in Providence, Rhode Island (Sept. 26–28), Corriere urged colleagues to step away from the computer and back toward the patient, highlighting
gether every two months to try to discuss ways we can help them fill in gaps in education,” explains Shaw. “Some have more exposure to different areas of vascular surgery than others. The website is a great enabler of this, helping provide access to trainees and young surgeons in any country, from Africa to South America.” Resources now available include contributions from the SVS, the European Society for Vascular Surgery (ESVS) and the Japanese Society for Vascular Surgery (JSVS).
In person, the WFVS has broadened its footprint at national and international conferences and meetings, which has included WFVS-dedicated sessions at the SVS Vascular Annual Meeting, the VEITHsymposium and Charing Cross (CX) International Symposium. And this month sees the WFVS stage its own annual symposium during the Vascular Society of South Africa (VASSA) Congress in Cape Town,
“We’ve put on a lot of different sessions to increase the federation’s visibility, and we have really worked to bring together resources that are accessible”
the event for which Shaw is preparing as she outlines the federation’s progress.
Cost is a limitation to expanding the Global Training Initiative, which has in part spurred the development of WFVS’ digital platform and access to its repository of educational resources. But a couple of key face-to-face opportunities have also emerged.
“We now have WFVS International Fellowships, which are part of a visiting scholar program, to help those from underserved regions who need more hands-on, advanced training,” Shaw continues. One is hosted by Jikei University in Tokyo, Japan, in which scholars spend three months under
shared decision-making and why it should become a central part of vascular care.
As director of the division of vascular surgery at Ohio State University’s Wexner Medical Center, Corriere has seen firsthand how time pressures and electronic record systems have made clinic visits less personal. He argued that effective care requires listening to patients.
“The patient is there to see me and my face,” Corriere said. “We need to not get so into the computer and input and billing that we start depersonalizing that individual in front of us. We need to get shared goals with them.”
This is especially true for patients with peripheral arterial disease (PAD), who often arrive at visits expecting immediate procedures, he said. When dealing with claudication, some believe they will face amputation without surgery or stents.
the leadership of Takao Ohki, MD. The other is a 12-month program at Houston Methodist DeBakey Heart & Vascular Center with Alan Lumsden, MD.
WFVS is also working with Iman Bayat, MBBS, from the Australia and New Zealand Society for Vascular Surgery (ANZSVS) on the Global Vascular Companionship, a mentorship-based program to create sustainable vascular units in underserved regions. “This is aimed at trying to help specific nations that have the capacity to build vascular units back home, but who just need that education,” Shaw details, pointing to examples of general surgeons in Barbados and Fiji being mentored by vascular surgeons to get units up and running. “We are endorsing and expanding the reach across the world. We also worked with the Rouleaux Club, the UK and Ireland’s vascular trainee association, to put on the Worrying Foot Competition at CX in London. The problem is funding for these trainees to do anything. The Worrying Foot Competition provided an opportunity to attend. But if you’re not in Europe, it’s an expensive trip, so how do you get that support?”
Further WFVS efforts are afoot to plug the gaps. A collaboration with the Journal of Vascular Surgery-Vascular Insights (JVS-VI) saw the development of a special edition focused on rare vascular diseases, which is available online and due to be published in print. It features such conditions as carotid body tumors, pediatric aneurysms and popliteal vein aneurysms. A multi-societal effort to bring together experience with uncommon vascular diseases, Shaw says the edition is aimed at providing perspectives from different parts of the world which “you may not get if you’re always coming from the U.S. or Europe.” In the same vein, the WFVS is collaborating with the Vascular Low Frequency Disease Consortium (VLFDC) to expand global access to data on rare diseases. Meanwhile, the WFVS council has been expanded. From two per society, the body now includes an additional representative from each constituent member society with an executive leader. “The goal was, again, to try to have more representation rather than less,” Shaw added. That inclusive approach extends to helping women vascular surgeons in areas of the world where barriers endure. “Speaking to colleagues in different parts of the world, it is clear there is less opportunity for exposure, especially for women,” she says. “There are fewer women vascular surgeons in places like Africa, for example, and, even in Romania, some of the female vascular surgeons may train but they don’t get to work independently, ending up as surgical assists. So, there are countries where I think that maybe we can help women advance and spread knowledge and experience.”
“There’s a clear argument that we need to be a little more open and engaging with our patients in treatment selection,” Corriere said.
Corriere emphasized the need to “rightsize treatment intensity,” saving procedures for only when they improve quality of life and reduce harm. He warned that both overtreatment and undertreatment can lead to poor outcomes.
“I think the biggest value for shared decision making is when we’re at a point of equipoise,” Corriere said. “That could be because we have exhausted non-invasive strategies enough and it’s time to pull the trigger on something else. Or it can also be in decisions regarding restenosis, where we’re on the merry-go-round and we’re trying to balance the benefit for doing something more invasive or not.”
Corriere and his colleagues conducted
a study that surveyed patients on how much they want to be involved in decision-making. Data showed that 93% of respondents wanted to choose a treatment together with their clinician. However, only about half reported ever being offered alternatives to a recommended procedure. Although shared decision-making has proven to be beneficial, Corriere noted how many clinicians believe it is just rolling over and doing whatever the patient wants. He said that should never be the case.
Corriere encouraged clinicians to ask their patients questions and really listen to their answers. “When you have goals and preferences that seem discordant with your clinical judgment, focus on the conversation and reorienting to get a mutually agreed upon set of goals and a plan,” he said.—Killian Meara
literature from SVS
By Bryan Kay
A READABILITY ANALYSIS OF 15 PUBLICLY available patient education materials from the SVS found that all but three exceeded the 8th-grade reading level, the threshold at which the average adult in the U.S. reads. Additionally, all 15 breached the 6th-grade reading level, the ceiling recommended by both the National Institutes for Health (NIH) and the American Medical Association (AMA).
The study was conducted by a team of researchers from Penn State College of Medicine in Hershey, Pennsylvania, led by senior author Faisal Aziz, MD, chief of vascular surgery at the institution, and presented during the 2025 Eastern Vascular Society (EVS) annual meeting in Nashville, Tennessee (Sept. 4–7) by Loui Othman, BS, a second-year medical
Despite calls for more simplified language in patient-facing resources, previous research has detailed how patient educa-
tion materials from various specialties exceed readability thresholds and strain patient understanding, Othman told EVS 2025.
The Penn State study used six validated readability tools to assess the difficulty of the SVS patient education materials, covering such vascular conditions as abdominal aortic aneurysm (AAA), carotid disease and peripheral arterial disease (PAD). Among their findings, Othman and colleagues reported that the reading material on AAA recorded the best reading ease score, while that for cerebrovascular disease registered the most difficult—found to be at the college reading level.
The study represented the first comprehensive readability analysis of the SVS materials, said Othman. “We used multiple calculators to enhance our confidence in recording the readability of each handout. Findings are consistent with and support previous research.”
The Penn State team recommend that the readability of the SVS materials be improved in order to enhance patient comprehension, engagement and adherence, he added.
A straw poll conducted at the close of the presentation to determine how many attendees referred patients to SVS materials online saw only a couple of raised hands. “That is also a big issue that needs to be addressed,” remarked moderator Mahmoud Almadani, MD, a vascular surgeon at Maimonides Medical Center in Brooklyn, New York.
SVS FOUNDATION SET TO LAUNCH
INNOVATION INSTITUTE AT VAM 2026
By Marlén Gomez
Vascular Surgery has identified the topic of innovations as one of its important goals. I am humbled and honored by the fact that this new institute was named after me. I believe this institute will be enriched by great contributions from our members,” said Enrico Ascher, MD, clinical professor in the Department of Surgery at NYU Grossman School of Medicine in
In 2025, Ascher was honored with the Medal of Innovation in Vascular Surgery during the Society’s Annual Meeting.
“These contributions are not limited to new devices but include innovative open and endovascular procedures, new concepts in training paradigms, new concepts in the medical and surgical management of vascular diseases, and any innovation that contributes to the betterment of the vascular patient,” said Ascher.
The Enrico Ascher Vascular Innovation Institute aims to foster a culture of innovation within the vascular community and provide mentorship and guidance from experienced surgeon-innovators. It will also deliver educational programming on key areas of innovation, offer seed funding for promising ideas and cultivate a
MECHANICAL
THROMBECTOMY SYSTEM FOR AV ACCESS SHOWS PROMISE, STUDY SHOWS
A RETROSPECTIVE ANALYSIS OF 64 PATIENTS
treated between 2022 and 2025 using a novel mechanical thrombectomy system to treat dialysis access thrombus showed function was restored in 91% of those treated.
Data from the study of the InThrill system (Stryker/ Inari Medcial) were presented by Nicole Ilonzo, MD, a vascular surgeon at NewYork-Presbyterian in Brooklyn, New York, at EVS 2025. AV fistulas and grafts
The study included patients with arteriovenous (AV) fistulas and grafts, with 31% of those treated having fistulas. “Clinical success, defined as restoration of access function for dialysis, was achieved in 91% of patients,” Ilonzo told EVS 2025.
“Primary patency at one month was 72%, higher than 40-60% range reported in studies using only balloon maturation techniques.”
Device-related complications were minimal, she said, with 3% experiencing trauma at the access site and another 3% having distal embolization. All were resolved intraprocedurally, Ilonzo added. “Importantly, there were no deaths, vessel perforations or major adverse events.”
The InThrill thrombectomy system “shows promise and is a safe and effective alternative to traditional AV access thrombectomy techniques,” she concluded.— Bryan Kay
growing innovator community anchored at VAM. Planned components of the launch include an innovation competition, a keynote session under the institute banner, a networking event connecting early-career surgeons with industry and funders, and educational content focused on entrepreneurship, technology translation and commercialization strategies.
The institute will also take ownership of the Roy Greenberg Distinguished Lecture, established in 2013 to celebrate innovation in vascular surgery. In further recognition of that legacy, the SVS plans to present the SVS Medal of Innovation in association with the Enrico Ascher Vascular Innovation Institute—directly linking the award to the program that embodies Ascher’s spirit of advancement and excellence.
“Creativity and innovations are essential goals of any medical or surgical specialty that wishes to prosper and lead,” said
“While it’s perfectly fine to collaborate with our non-surgical colleagues, we need to continue to lead this race for creativity and innovations in this field” ENRICO ASCHER
Ascher. “It’s not a secret that we are facing increasingly strong competition from other specialties that manage patients with vascular diseases. While it’s perfectly fine to collaborate with our non-surgical colleagues, we need to continue to lead this race for creativity and innovations in this field.”
A critical element of the institute mission is preparing participants to evaluate market needs, navigate regulatory requirements and communicate their ideas effectively. The Innovation Task Force has identified this kind of training as essential, particularly in the early stages of innovation.
To meet this need, the SVS is exploring partnerships with providers of entrepreneurial training. One model under consideration includes a scalable online course covering the fundamentals of innovation and business planning, paired with individualized coaching to help participants prepare professional pitch presentations for review by business advisors or potential funders.
“Let us not forget that a single idea originating from any vascular surgeon can revolutionize our specialty,” Ascher said. “Recognize needs, trust your ideas, and believe you can contribute—no matter your role. If inspiration strikes, jot it down, and if it still makes sense later, pursue it with all your heart. Don’t give up. If needed, reach out to the newly formed Institute for Vascular Innovations.”
Loui Othman
COMMENT& ANALYSIS
A story foretold: The
AMA, Ed Annis, Medicare and the loss of physician autonomy
By Arthur Palamara, MD
IN 1979, AFTER THREE YEARS OF GROUP practice, I opened an office as a solo vascular surgeon. With a wife, three children and a mortgage to support, the move was gutsy. To survive, no referral was too small, no operation too minor to be ignored. Every patient encounter was appreciated. A partner joined and we prospered. Despite hard-work and talent, clouds were on the horizon, as we realized that small groups were disadvantaged by omnivorous insurance companies who cared little for good outcomes. Our practice was assimilated by a major hospital. After 12 years and my partner’s death, it became apparent that my employer and I had dissimilar agendas. With little explanation, I am forced to move on.
Since my energy and ability remain vigorous, the need to re-emerge in private solo practice provides the only option. I will again depend solely upon my wit and resources. Having avoided expensive doctor traps like airplanes, boats, cars and divorce, financial security is not an issue. Still, creating a practice after 47 years reveals a completely different mine-laden medical landscape.
Facing so many daunting obstacles, starting a practice from scratch may no longer be possible. Easier for me with money in the bank, it would seem to be essentially impossible for a doctor out of fellowship with $250,000 worth of student debts.
Insurance companies and hospitals have altered the environment to the point where physicians are now considered a “commodity.” The U.S. spends $4.9 trillion on healthcare (2023), with only $1.18 trillion going to doctors and “clinical service.” (Since 80% of doctors are now employed, I’m not sure how ChatGPT arrived at that figure.) Most employed doctors working for hospitals receive salaries supplemented at facility rates, which are quite a bit (!) higher than procedural rates.
Considering the remaining $3.8 trillion, and since other developed countries spend half of what the U.S. spends, one can assume that 50% goes for administration and/or corporate profit. Our outcomes are dismal, somewhat worse than 18% in world rankings. How did this come about? Or rather, how did doctors and our powerful American Medical Association (AMA) allow this to happen?
On May 20, 1962, President John F. Kennedy gave a speech at Madison Square Garden in New York outlining the foundation of Medicare. The King-Anderson bill, as it was known, was to be part of Social Security. As outlined, it would only cover 66% of the hospital bill, the patient having to fork over the rest. Kennedy opined: “The doctors don’t comprehend what we are trying to do. We don’t cover doctors’ bills here. We don’t affect the freedom of choice. You can go to any doctor you want.”
The AMA was vehemently opposed to this bill.
Jesuit-trained Dr. Ed Annis of Miami made numerous speeches on the AMA’s behalf in 1961. In fact, he debated Sen. Hubert Humphrey on television, vociferously arguing against its passage. Jesuit graduates are great debaters, and his Marquette training served him well. The AMA gave him the perfect opportunity. They rented Madison Square Garden, and, on television, Dr. Annis spoke to an empty stadium. He argued that the legislation would impose an “unpredictable burden on every working taxpayer and will lower the quality and availability of hospital services throughout our country.” The overture was not lost on the U.S. public and the event enhanced both the reputation and power of the AMA.
President Kennedy was assassinated in 1963 and never enjoyed the fruits of his goal of providing healthcare for all. His successor, President Lydon B. Johnson, passed the Medicare and Medicaid Act in 1965. This legislation remains an essential part of the American fabric. Unarguably, Medicare and Medicaid have saved countless lives. Ed was a terrific guy with a twinkle in his eye. He loved telling the story of his debates with labor leaders, politicians and, indeed, the Madison Square Garden speech. When he was chosen president of the AMA (out of turn), he insisted that the elected president not be denied his year in office. He was quite proud that he never missed an AMA meeting for some 50 years until his passing in 2009. While he may have been on the wrong side of history, Ed never regretted his stance on Medicare and felt that the loss of physician autonomy and poor patient care were the result. He may not have been wrong.
Although Medicare/Medicaid are firmly entrenched, no one could have anticipated their derivatives: health maintenance organizations (HMOs) and Medicare Advantage plans, called by some “Medicare Dis-advantage.” With justifiable reason. In spite of increased utilization and pricey pharmaceuticals, Medicare Advantage plans enjoyed their highest gross margins of profit in 2023, $1,982 per enrollee. Medicare Advantage total revenue reached $384 billion in 2023.
es Act; upcoding fraud. This is but a partial list. Patient frustration is evidenced by the unexpected outpouring of sympathy for a lone assassin who gunned down the CEO of UnitedHealthcare in December. Not that people endorse violence as a solution, but frustration with insurance companies is so great that the CEO’s murder poked a sleeping bear.
And we physicians—who do most of the work—have not seen an increase in reimbursement since 2000. Even more insulting is the fact that physician pay (per the Medicare Physician Fee Schedule) was cut 2.83% while Medicare Advantage plans received an additional 3.2%! President Donald Trump’s One Big Beautiful Bill Act includes a 2.5% Medicare increase for 2026. Without additional legislation, Congress will be obligated to remove this increase in 2027.
Perhaps his frustration after hearing the same complaints verbalized by the membership culminated in a fiery speech by outgoing AMA President Bruce Scott. It was simply titled: “We’re not going to take it anymore!” Regretfully, the only fatigued solution they offer is to give more money to politicians in the forlorn hope that they will eventually see the error of their ways and direct federal funding to those who provide hands-on patient care. Yet at every turn, health insurers construct new roadblocks. Their requiring physicians to obtain prior authorization has made treating patients more difficult and inserts another impediment to patient care, as well as cost to physicians. UnitedHealthcare bought InterQual to determine medical necessity, which is akin to Health and Human Services Secretary Robert F Kennedy Jr. assessing the value of vaccines.
Although Medicare/ Medicaid are firmly entrenched, no one could have anticipated their derivatives: HMOs and Medicare Advantage plans, called by some ‘Medicare Dis-advantage’
While I am not sympathetic to their plight, 2024 saw a reduction in profitability because of increased utilization by seniors, leading to reduced benefits and disposing of unprofitable markets. Negative patient reaction caused President Joe Biden to reduce overpayments, adjustment of reimbursement rates and risk adjustment.
That insurance giant UnitedHealthcare is far from a paragon of virtue amid all of this is exemplified by a string of lawsuits: misleading investors; insider trading; NaviHealth algorithm to deny rehabilitation; algorithms for care denials; antitrust acquisition of Amedisys (home healthcare and hospice) and Optum; the No Surpris-
AMA leadership desperately pleads with Congress to tie Medicare funding to the Medicare Economic Index. Congress, faced with a $35 trillion deficit, and wars in Eastern Europe and the Middle East, is unlikely to reform healthcare anytime soon.
So where is a modern Dr. Ed Annis? Why does the AMA not rent out Madison Square Garden and preach to the multitude who stand ready to support righteous leadership? Why have they abandoned their role of patient advocacy? Why do they remain content to fiddle with corporate mandated impositions.
To the good, the AMA House of Delegates voted to pursue a class action lawsuit against health insurers’ prior authorization by a 80–20 vote with over 700 delegates voting. Maybe that’s a start. Maybe we can go further, using the McCarran-Ferguson exemptions (named the Competitive Health Insurance Reform Act of 2021) that exposes the pernicious conduct of health insurance companies to antitrust laws. That would serve AMA members and our patients better than pleading for legislative relief. Until then, I will have to be content with earning $475 for a below-knee amputation and $400 for an arteriovenous fistula. But little can compete with the satisfaction of performing a successful amputation or the gratitude of a patient.
ARTHUR PALAMARA is a vascular surgeon practicing in Hollywood, Florida. He is active in county, state and national medical organizations
ADVOCACY CONFERENCE
VASCULAR SURGEONS DESCEND ON DC: MAIDEN SVS LEADERSHIP CONFERENCE TAKES ADVOCACY EFFORTS TO LEGISLATIVE DOORSTEP
By Marlén Gomez
THE SVS HELD ITS INAUGURAL
Advocacy and Leadership Conference Sept. 14–16, drawing vascular surgeons, trainees and healthcare advocates from across the country to the nation’s capital for three days of policy education, leadership training and direct engagement with lawmakers.
The Washington, D.C., conference was designed to empower participants to become more effective advocates for vascular health. Through a combination of keynote addresses, policy briefings, interactive workshops and Capitol Hill meetings, attendees gained firsthand experience in shaping healthcare policy.
Lauren West-Livingston, MD, a fourthyear integrated vascular surgery resident at Duke University and a new member of the SVS Government Relations Committee, attended the summit in an effort to get a head
start on advocacy as a vascular surgeon. “I want to get started as early as possible to make as big a change as possible,” she said.
Leadership sessions led by SVS Executive Director Kenneth Slaw, PhD, and Advocacy Council Chair Megan Tracci, MD, JD, focused on strategic communication and navigating the policy landscape.
Participants examined key legislative issues affecting the specialty, including reimbursement reform, prior authorization and regulatory burdens. Dutch Rojas, a healthcare entrepreneur, spoke about innovation in care delivery. Peggy Tighe, a Washington-based attorney and lobbyist, provided insights into efforts to streamline the prior authorization process. A panel of congressional health staffers offered a bipartisan perspective on the complexities of advancing health legislation.
“This conference was exceptionally well organized and provided invaluable insights into the legislative process and the current bills under consideration that directly impact vascular surgeons nationwide,” said Adam W. Beck, MD, division director of vascular surgery and endovascular therapy at the University of Alabama at Birmingham.
“It greatly enhanced my understanding of
“ This conference was exceptionally well organized and provided invaluable insights into the legislative process and the current bills under consideration that directly impact vascular surgeons nationwide”
ADAM W. BECK
SVS members attend the Advocacy and Leadership Conference
advocacy, and the role physicians can play in shaping health policy.”
Surgeons and advocates met directly with members of Congress and senior staff, including Reps. Ami Bera, D-Calif.; Raja Krishnamoorthi, D-Ill.; and Mariannette Miller-Meeks, R-Iowa. Mehmet Oz, MD, the 17th administrator for the Centers for Medicare & Medicaid Services (CMS), addressed attendees on Medicare policy and the agency’s future direction.
Soapbox Consulting led practical exercises to prepare attendees for legislative meetings, while the SVS Political Action Committee (PAC) hosted a networking event that allowed participants to connect with lawmakers in a more informal setting. Tracci emphasized the importance of surgeon involvement in health policy.
To stay informed on advocacy, visit vascular. org/Advocacy for updates on legislative developments and opportunities to support vascular health.
SOCIETY BRIEFS
Compiled by Marlén Gomez and Bryan Kay
Stanford vascular surgery blends team bonding and exercise in first SVS Step Challenge gathering
THE STANFORD DIVISION OF Vascular Surgery launched its first in-person SVS Foundation Vascular Health Step Challenge on Sept. 7, bringing together more than 100 participants to raise awareness for peripheral arterial disease (PAD) during PAD Awareness Month.
Jason Lee, MD, professor of surgery and division chief, assisted in the planning of the event that featured a 1.3-mile walk around Stanford’s campus. Participants collectively logged more than 250,000 steps in just 45 minutes and raised $3,000 for the Foundation’s event.
“We started this summer by trying to gather interest in it,” Lee said. “We realized the beginning of fall was a good time to bring
our clinic staff, faculty and trainees together, which is how we were able to get 100 people to show up on a Sunday morning.”
The walk included faculty, fellows, residents, staff and families—many of whom brought children and their fourlegged companions. “I was happy to see us contribute a quarter of a million steps to the Step Challenge,” Lee said. “It was all in the name of raising awareness for PAD.”
Due to the event’s success, the Stanford team is considering making Sunday walks a regular tradition. “It was so much fun, honestly,” he said. “We’re thinking about every Sunday morning moving forward—just getting some bagels and coffee and gathering the vascular team together for a walk.”
The SVS Foundation, an organization dedicated to supporting vascular education and research, will utilize the fundraising efforts from the challenge to make critical research investments, such as to the Vascular Care for the Underserved (VC4U) award.
“The Lee family has always been happy to support the SVS Foundation because of how much it has helped my career,” he said. “Now I want to support all the initiatives to help our medical students, trainees and young career faculty.”
Looking ahead, Lee said the team may expand the challenge. “In the upcoming years, we might turn it into a race or a run or a bike challenge,” he added.
CHANGING OF THE GUARDS: REGIONAL VASCULAR SOCIETIES WELCOME NEW LEADERSHIP FIGURES
FOUR OF THE MAJOR U.S. REGIONAL VASCULAR SOCIETIES PARADED their new leaders during the September glut of annual meetings. Benjamin Jackson (top right), MD, chief in the Division of Vascular and Endovascular Surgery at Lehigh Valley Heart and Vascular Institute in Allentown, Pennsylvania, became the new Eastern Vascular Society (EVS) president during the 2025 EVS annual meeting in Nashville (Sept. 4–7). Palma Shaw, MD, professor of surgery at State University of New York in Syracuse, became the society’s presidentelect. Jackson takes over from Brajesh K. Lal, MBBS, a professor of surgery in the University of Maryland School of Medicine in Baltimore.
Over on the West Coast, David Rigberg (bottom right), MD, clinical professor of surgery at the UCLA Gonda School of Medicine in Los Angeles, has taken over as president of the Western Vascular Society (WVS). Rigberg became the 2025–26 WVS president at the society’s annual gathering in Ojai, California (Sept. 14-17). He took over from the 2024–25 president, Ahmed Abou-Zamzam, MD, professor and chief in the Division of Vascular Surgery at Loma Linda University Health in Loma Linda, California. Niten Singh, MD, professor and chief in the Division of Vascular and Endovascular Surgery at the University of Washington in Seattle, is now president-elect.
In the Midwest, Ross Milner (top left), MD, the Louis Block professor of surgery and chief of vascular surgery at the University of Chicago, became the new president of the Midwestern Vascular Surgical Society (MVSS) in Cincinnati, Ohio. Milner took over from outgoing President Patrick Muck, MD, chief of vascular surgery at Good Samaritan Hospital in Cincinnati, during the 2025 MVSS annual meeting (Sept. 18–20) in the city. The new MVSS president-elect is Rachael Nicholson, MD, previously MVSS treasurer and director of the Division of Vascular Surgery at the University of Iowa in Iowa City.
In New England, Alik Farber (bottom left), MD, surgeon-in-chief at Boston Medical Center and James Utley professor and chair of surgery at Boston University Chobanian and Avedisian School of Medicine, became the new president of the New England Society for Vascular Surgery (NESVS). Farber took over from outgoing president Jessica Simons, MD, director of the vascular surgery residency program at UMass Memorial Health and professor of surgery at the UMass Chan Medical School, during the 2025 NESVS annual meeting (Sept. 26-28) in Providence, Rhode Island. The new NESVS president-elect is Cassius Chaar, MD, associate professor of surgery in the division of vascular surgery and endovascular therapy at the Yale School of Medicine.
Apply by Nov. 1 for SAVC awards
THE SVS SECTION ON AMBULATORY VASCULAR CARE (SAVC) WILL close nominations for its 2025–26 awards on Nov. 1. SVS members are encouraged to recognize their peers by submitting nominations for three distinct honors.
The SAVC Presentation Award honors vascular surgeons who have completed clinical research projects in office-based labs (OBLs) or ambulatory surgery centers (ASCs). The SAVC Research Seed Grant provides $10,000 to each of three recipients to support research conducted in office-based labs (OBL) or ambulatory settings.
The grant is intended to fund a data analyst to evaluate research data for actionable insights, quality improvement and enhanced patient care. The grant is renewable for a second year based on first-year outcomes. The Excellence in Community Practice Award recognizes a vascular surgeon who has demonstrated leadership and service
To learn more, visit vascular.org/Awards.
SVS receives slew of VAM 2026 ‘Hot Topics’ session
proposals
PROPOSALS FOR THE NEW “HOT Topics” session at the 2026 Vascular Annual Meeting (VAM) recently drew in a slew of responses for the inaugural iteration of the program feature. Hot Topics sessions are designed to feature short, high-impact presentations on emerging issues, innovations and practice-changing developments in vascular surgery. Each proposal required an outline of a single lecture topic that can be delivered in 15 minutes or less and focus on clinical relevance and timeliness, organizers said. Submissions sent by email or other methods were not be considered. Selected presenters will be notified by the end of October and will work with the SVS Postgraduate Education Committee to finalize session content. VAM 2026 will take place June 10–13 at the Hynes Convention Center in Boston.
For more information on Hot Topics and the VAM program in general, visit vascular.org/Hot-Topics and at vascular.org/VAM
Online Wound Care Curriculum offers ondemand education for vascular teams
STAY UPDATED ON THE LATEST advancements in wound care with the SVS, Society for Vascular Nursing, and American Podiatric Medical Association’s Wound Care Curriculum. This program, now available through SVS VascuLEARN, offers vascular professionals flexible, evidence-based training that is applicable immediately.
The online module includes 27 ondemand videos, allowing participants to earn up to 6.25 continuing education credits, including AMA PRA Category 1 Credits, ABS-accredited CME, APMA CECH and CNE. The course features pre- and post-tests to assess knowledge and is available through Feb. 17, 2028. To register, visit vascular.org/WoundCare
CLINICAL&DEVICENEWS
Compiled by Bryan Kay
FastWave Medical appoints principal investigators for IVL pivotal trial
VENITA CHANDRA, MD, CLINICAL PROFESSOR OF SURGERY at Stanford Health Care in Stanford, California, will serve as a co-principal investigator for the investigational device exemption (IDE) pivotal trial of Artero, FastWave Medical‘s peripheral electric intravascular lithotripsy (E-IVL) system. The news recently emerged as the company announced the appointment of its principal investigators and steering committee team for the study.
Sahil Parikh, MD, director of endovascular services at Columbia University Irving Medical Center in New York, joins Chandra as a co-principal investigator. They are also joined by Eric Secemsky, MD, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston; Marc Bonaca, MD, a vascular medicine and cardiology doctor at the University of Colorado in Boulder; and Daniel Clair, MD, professor and chair of the department of vascular surgery at Vanderbilt University Medical Center in Nashville, who will help guide the trial’s clinical strategy.
The study will evaluate the safety and effectiveness of the Artero IVL system in treating peripheral arterial disease (PAD).
“The key question isn’t just whether a device works, but whether it makes procedures more efficient and provides physicians with a more predictable tool for treating patients with complex arterial disease,” said Chandra. “I’m excited to see how the promise of FastWave’s peripheral IVL system plays out in this study.”
TERUMO AORTIC AND BENTLEY HAVE announced their partnership in a clinical study in the U.S. as they aim to obtain Food and Drug Administration (FDA) investigational device exemption (IDE) approval for Terumo’s fenestrated Treo device, in combination with Bentley’s BeFlared fenestrated endovascular aneurysm repair (FEVAR) stent graft system for FEVAR procedures. The IDE submission is planned for the first half of 2026.
Through this collaboration, Terumo Aortic and Bentley noted in a press release that they aim to bring their FEVAR solutions to benefit U.S. patients suffering from complex abdominal aortic aneurysms.
Following the completion of the joint clinical study and FDA approval, both companies plan to independently market their products in the U.S.
Terumo Aortic shared that its fenestrated Treo device offers a patient-specific solution tailored to the anatomical conditions and clinical needs for treating aortic aneurysms. The company detailed that, to ensure perfusion of vital organs, the device can be designed to include up to five fenestrations, requiring reliable bridging stents to maintain perfusion to the target vessels.
MEDTRONIC HAS FULLY ROLLED OUT DISTRIBUTION of the Neuroguard integrated embolic protection (IEP) system for carotid artery disease following its limited market distribution, the company announced. This follows the announcement earlier this year of an exclusive U.S. distribution agreement between Medtronic and Contego Medical, developer of the device.
Neuroguard is marketed as the first carotid stent to offer a 3-in-1 technology, combining a stent, post-dilation balloon and filter. Data from the PERFORMANCE II study of the device demonstrated no major strokes, neurological deaths, stent thromboses or clinically driven target lesion revascularization, despite 34.5% severely calcified lesions at 30 days and one year, the company stated in a press release.
Contego Medical is currently evaluating the Neuroguard IEP system with a next-generation direct transcarotid access and protection system, TCARIEP, to demonstrate safety and effectiveness in the PERFORMANCE III trial.
GREGORIO SICARD, PAST SVS PRESIDENT, ADVOCATE FOR LATIN AMERICAN SURGEONS, CELEBRATED SURGICAL EDUCATOR, DIES AGED 81
By Malachi Sheahan III, MD, and Marlén Gomez
Gregorio A. Sicard, MD, a transformative figure in vascular surgery and a revered mentor to generations of surgeons, has died. He was 81.
Sicard was widely recognized for pioneering contributions to vascular surgery, particularly in developing and advocating for endovascular procedures. His career spanned more than four decades, during which he helped shape the field through clinical innovation, leadership and advocacy.
In 2018, Sicard was honored with the SVS Lifetime Achievement Award, the society’s highest distinction. He was celebrated as a “surgeon’s surgeon,” a title that reflected both his technical excellence and his unwavering commitment to advancing the specialty during the rise of minimally invasive techniques.
Sicard spent nearly his entire surgical career at Washington University School of Medicine in St. Louis, where he completed his residency and fellowship before joining the faculty. In 1983, he founded the institution’s Vascular Surgery Section and, two years later, he received a promotion to professor of surgery. In 1998, he assumed the role of chief of the Division of General Surgery, which encompassed vascular surgery. In 2006, he was named the Eugene M. Bricker Professor of Surgery.
His legacy at Washington University was further cemented in 2011, when the Gregorio A. Sicard Professorship was established in his honor.
As SVS president (2004–2005), Sicard played a pivotal role in the merger of the SVS and the American Association for Vascular Surgery (AAVS), helping unify the specialty during a critical period of consolidation. He later chaired the SVS Outcomes Committee, working closely with the Food and Drug Administration (FDA) and Centers for Medicare & Medicare Services (CMS) to advocate for evidence-based, patient-centered policies that recognized the essential role of vascular surgeons in endovascular care.
Born and raised in rural Puerto Rico, Sicard was the son of a surgeon and earned his medical degree from the University of Puerto Rico. He graduated in 1972 and went on to mentor more than 50 fellows, publish hundreds of articles and book chapters, and helped shape the careers of countless vascular surgeons around the world.
Sicard’s legacy lives on in the surgeons he trained, the patients he cared for and
the field he helped mold. The vascular community will remember his surgical brilliance as well as his humility, generosity and enduring dedication to vascular surgery.
We are pleased to offer a few reflections from Sicard’s friends and mentees.
Anton N. Sidawy, MD, past SVS president
A true friend to so many, Greg Sicard will be remembered for his infectious laugh, his captivating stories, and his remarkable ability to make everyone feel like the most important person in the room. He had a gift for connecting with people from all walks of life, especially surgeons, and his gregarious spirit led him to amass a vast circle of friends from all over the world who will deeply miss his warm presence and generous heart and spirit.
bond, born from his generosity, continues to this day. His love for life was contagious; at any gathering, he was the vibrant center of a crowd, a source of stories and laughter that could be heard from a distance. That image of him, surrounded by friends, is the one I will forever hold dear. Rest in peace, my friend.
R. Clement Darling III, MD, past SVS president
Being one of Greg’s friends was very special. He was warm, thoughtful, caring and playful. Most knew Greg for his tremendous surgical skill, intellect and ability to cut through the BS. But after a few cigars and drinks, what I will miss most is his stories, infectious laughter and wonderful spirit.
Much like in the operating room, one could not question who was in charge, and he commanded the scene when we got together in any arena.
Greg had an unforgettable laugh, loved to tell stories and mix it up with friends. His fellows were always very special to him. They were his “kids.” Everyone knew they had to get everything set up perfectly for “the Great One,” as he was known in the operating room, or else he was doing the entire operation.
We had known each other for many years, but we started working closely together when we served on the SVS Council and SVS Outcomes Committee, and especially when he became president of the SVS while I was serving in the secretary position. At the time, our specialty and Society were still going through a period of consolidation after the SVS and AAVS merged in 2003, a year before Greg assumed the presidency of SVS. I followed carefully what he was doing to promote our specialty nationally and internationally, steer our Society in the right direction, and help produce the next well-trained generation of vascular surgeons.
Greg Sicard was a master aortic surgeon, visited by surgeons from the U.S. and all over the world to learn his surgical techniques. His fellows adored him and they all stayed in contact with him long after they graduated from their fellowships. Through him, I got to know a good number of them; all those I met followed in his footsteps and became excellent vascular surgeons in their own right.
Greg had a remarkable gift for weaving people together. I’ll always remember the way he effortlessly brought me into his circle during an annual dinner in St. Louis, introducing me to a few of his friends, mainly faculty members at Washington University who would go on to become my own. Our
contagious laugh, his eternal positive attitude, and his active involvement in the education of medical students, trainees, and colleagues alike... I was fortunate to closely work with him for over 20 years and follow him as the chief of vascular surgery at Washington University School of Medicine and Barnes Jewish Hospital, as well as carry the professorship that bears his name since 2011. He is a tremendous loss to our vascular surgery community and he will be greatly missed.
Francis Caputo, MD, Cleveland Clinic, Ohio
Dr. Sicard was known for his clinical acumen, surgical aptitude and dedication to his family. I had the distinct privilege to train under him, ultimately resulting in his mentorship but most importantly resulting in his friendship.
In terms of his tenure as a vascular surgeon, the one thing he was most proud of was the lineage he left behind. He loved seeing his trainees succeed, often becoming leaders at their institutions. He loved even more the comradery of his trainees, even when of different generations. The family of Barnes graduates is saddened by the loss of their “papa” and grateful for the lessons learned.
Greg was way bigger than a few paragraphs. He was larger than life, a true friend; a great, talented surgeon, a dedicated family man, and he loved those that worked with him, at work and at the SVS.
I Ioved Greg and I will miss the big bear hug, the jokes, the cigars, the chiding (especially being called “kid”), and, most of all, that laugh. How I loved that laugh. We will all miss the great one.
“[Greg] was larger than life, a true friend, a great, talented surgeon, a dedicated family man and loved those that worked with him, at work and at the SVS”
R. CLEMENT DARLING III
Luis Sanchez, MD,
Gregorio A. Sicard distinguished professor of surgery and cardiology at Washington University
He was a vascular surgery regional, national and international leader that will always be remembered with special affection for his generosity, sharing his extensive knowledge and expertise in vascular surgery. His vision of the future of our field, his
Yazan Duwayri, MD, Emory University, Georgia
During my fellowship, and even to this day, I fear disappointing Dr. Sicard—not because he was harsh, but because I held him in such high regard. The drive to meet his standard, is something only Wash U alumni truly understand.
I’m grateful for having had Dr. Sicard in my life. I try to emulate him, and I know I’m not alone. All of us who trained under him carry pieces of him in how we operate, how we teach and how we carry ourselves. He loved being a surgeon and never sought importance beyond that. “Importance” sought him. That pride in the craft is what made everyone respect him—and what makes his legacy so enduring.
Jeffrey Jim, MD, Allina Health Minneapolis Heart Institute
I feel so lucky to have trained under Dr. Sicard and am forever grateful for all that he had done for me. For two decades, he was a teacher, a colleague and, most importantly, a friend. He was considered a giant in vascular surgery and a “surgeon’s surgeon.” For me and his trainees, he was just “papa.”
Dr. Sicard was always ready to listen to give wise, “old-man” advice. He only wanted the best for me and was incredibly generous and supportive of all his trainees.
Dr. Sicard was the centerpiece that deeply connected all the Wash U graduates, even those that trained decades apart. We all lost our surgical father figure and mourn with his family.
We miss him dearly and will keep him close in our hearts and minds.
Gregorio A. Sicard
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System
INDICATIONS
The Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is indicated for improving luminal diameter in infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI) and total scaffolding length up to 170 mm with a reference vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm.
CONTRAINDICATIONS
The Esprit™ BTK Everolimus Eluting Resorbable Scaffold System is contraindicated for use in:
• Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or the post-procedural antiplatelet regimen. Patients with hypersensitivity or contraindication to everolimus or structurally related compounds or known hypersensitivity to scaffold components poly(L-lactide), poly(D, L-lactide), and platinum.
WARNINGS
• This device is intended for single use only. Do not reuse, reprocess, or re-sterilize. Note the product “Use-by” date on the package. Reuse, reprocessing, or re-sterilization may compromise the structural integrity of the device and / or delivery system and / or lead to device failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and / or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device and / or delivery system may lead to injury, illness, or death of the patient.
• The Esprit™ BTK System is intended to perform as a system. The scaffold should not be removed for use with other dilatation catheters.
• The Esprit™ BTK System should not be used in conjunction with other non-everolimus drug eluting devices in the same vessel as the Esprit™ BTK Scaffold.
• It i s not recommended to use this scaffold to treat lesions located at any joint or other hinge points, such as the knee or ankle. The recommended region for below-the-knee (BTK) treatment with the Esprit™ BTK Scaffold is the infrapopliteal arteries at a location ≥ 10 cm above the proximal margin of the ankle mortise. The Esprit™ BTK Scaffold has not been tested for use outside the recommended implant locations.
• Th is product should not be used in patients with aneurysms immediately adjacent to the scaffold implantation site.
• Insertion of the Esprit™ BTK System and implantation of the scaffold should be performed only under fluoroscopic observation with radiographic equipment providing high resolution images.
• Quantitative imaging is strongly recommended to accurately measure and confirm appropriate vessel sizing (reference vessel diameter ≥ 2.5 mm). If quantitative imaging determines a vessel size < 2.5 mm, do not implant the Esprit™ BTK Scaffold.
Adequate lesion preparation prior to scaffold implantation is required to ensure safe delivery of the scaffold across the target lesion. It is not recommended to treat patients having a lesion that prevents complete inflation of an angioplasty balloon.
• Successful pre-dilatation with residual diameter stenosis of < 30% by visual estimation is required for treatment of the target lesion; < 20% by visual estimation is preferred.
• En sure the scaffold is not post-dilated beyond the allowable expansion limits.
• Use of appropriate anticoagulant and / or antiplatelet therapy per standard of care is recommended for use of this scaffold system.
Th is product should not be used in patients who are not likely to comply with the recommended antiplatelet therapy.
• Judicious selection of patients is necessary, since the use of this device carries the associated risk of scaffold thrombosis, vascular complications, and / or bleeding events.
PRECAUTIONS
Scaffold placement should not be performed in patients with known allergies to contrast agent that cannot be medically managed.
• It i s not recommended to treat patients having a lesion with excessive tortuosity proximal to or within the lesion.
• When multiple scaffolds are required, only combinations of Esprit™ BTK Scaffolds must be used. Any potential interaction with other drug-eluting or coated devices has not been evaluated.
• The delivery system is intended for deployment of the scaffold only and should not be used to dilate other locations.
• Implantation of the scaffold should be performed only by physicians who have received appropriate training.
• As w ith all catheter-based procedures, scaffold placement should be performed at facilities where patient can be prepared for necessary intervention and / or surgical removal of the device and vessel repair as per facility protocol.
• Pre-dilatation should be performed with an angioplasty balloon. Cutting or scoring balloons can be used per physician discretion, if the lesion appears to be mildly calcified.
• Fa ilure to pre-dilate the vessel may impair nominal / optimal scaffold delivery.
• Implanting a scaffold may lead to dissection of the vessel distal and / or proximal to the scaffold, requiring additional intervention.
Note: In cases of bailouts, bailout treatment of the target lesion can be done using the Esprit™ BTK Scaffold of the appropriate length. If an appropriate length Esprit™ BTK Scaffold is not available, physicians should use standard of care.
• An u nexpanded scaffold may be retracted into the introducer sheath one time only. An unexpanded scaffold should not be reintroduced into the artery once it has been pulled back into the introducer sheath.
• Post-dilatation is strongly recommended for optimal scaffold apposition. When performed, post-dilatation should be performed at high pressure (> 16 atm) with a non-compliant balloon up to 0.5 mm larger than the nominal scaffold diameter.
• Use an appropriately sized non-drug coated balloon to pre-dilate the lesion. When treating a long lesion, scaffold the distal portion of the lesion prior to scaffolding the proximal portion of the lesion.
• En sure that the scaffolded area covers the entire lesion / dissection site and that no gaps exist between scaffolds.
The extent of the patient’s exposure to drug and polymer is directly related to the number of scaffolds implanted. The safety of everolimus, polymer, and polymer breakdown products was evaluated in preclinical studies and the biocompatibility assessment of the Esprit™ BTK Scaffold.
• The safety and effectiveness of the Esprit™ BTK Scaffold in patients with prior brachytherapy of the target lesion or the use of brachytherapy for treatedsite restenosis in the Esprit™ BTK Scaffold have not been established. Both vascular brachytherapy and the Esprit™ BTK Scaffold alter arterial modeling. The potential combined effect on arterial remodeling by these two treatments is not known.
• The safety and effectiveness of the Esprit™ BTK System have not been established in clinical trials with the use of either mechanical atherectomy devices (directional atherectomy catheters, rotational atherectomy catheters) or laser atherectomy catheters.
• Formal drug interaction studies have not been performed with the Esprit™ BTK Scaffold because of limited exposure to everolimus eluted from the scaffold.
• Everolimus, the Esprit™ BTK Scaffold’s active pharmaceutical ingredient, is an immunosuppressive agent. Therefore, consideration should be given to
patients taking other immunosuppressive agents or who are at risk for immune suppression.
Oral everolimus use in renal transplant and advanced renal cell carcinoma patients was associated with increased serum cholesterol and triglyceride levels, which in some cases required treatment.
Non-clinical testing has demonstrated the Esprit™ BTK Scaffold is MR Conditional. A person with the Esprit™ BTK Scaffold may be safely scanned under the following conditions. Failure to follow these conditions may result in injury.
• Static magnetic field strength of 7 Tesla or less
• The Esprit™ BTK Scaffold should not migrate in this MRI environment. MRI at 7 Tesla or less may be performed immediately following the implantation of the Esprit™ BTK Scaffold.
POTENTIAL ADVERSE EVENTS
Potential adverse events include, but are not limited to: Allergic reaction or hypersensitivity to contrast agent, anesthesia, scaffold materials (poly[L-lactide] [PLLA], poly[D, L-lactide] [PDLLA], platinum, or everolimus), and drug reactions to anticoagulation or antiplatelet drugs
Va scular access complications which may require transfusion or vessel repair, including:
• Infection – local and systemic (including postprocedural)
• Fever Blood cell disorders including heparininduced thrombocytopenia (HIT) and other coagulopathy
• Death
• Sy stem organ failures: Cardiac Failure
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at manuals.eifu.abbott for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. This material is intended for use with healthcare professionals only.
Illustrations are artist’s representations only and should not be considered as engineering drawings or photographs.
Information contained herein for DISTRIBUTION in the U.S. ONLY.
Abbott
3200 Lakeside Dr., Santa Clara, CA 95054 USA, Tel: 1.800.227.9902
The risks described below include the anticipated adverse events referenced in the contraindications, warnings, and precautions sections of the everolimus labels / SmPCs and / or observed at incidences ≥ 10% in clinical trials with oral everolimus for different indications. Refer to the drug SmPCs and labels for more detailed information and less frequent adverse events.
• Bleeding and coagulopathy (including hemolytic uremic syndrome [HUS], thrombotic thrombocytopenic purpura [TTP], and thrombotic microangiopathy; increased risk with concomitant cyclosporine use)
• Con stipation
Cough
• Diabetes mellitus
• Diarrhea
Dy spnea
• Embryo-fetal toxicity
• Er ythema
Ery throderma
• Headache
• Hepatic artery thrombosis (HAT)
Hepatic disorders (including hepatitis and jaundice)
• Hypersensitivity to everolimus active substance, or to other rapamycin derivates
Hy pertension
• In fections (bacterial, viral, fungal, or protozoan infections, including infections with opportunistic pathogens). Polyoma virus-associated nephropathy (PVAN), JC virus-associated progressive multiple leukoencephalopathy (PML), fatal infections and sepsis have been reported in patients treated with oral everolimus.
Kidney arterial and venous thrombosis
• La boratory test alterations (elevations of serum creatinine, proteinuria, hypokalemia, hyperkalemia; hyperglycemia, dyslipidemia including hypercholesterolemia and hypertriglyceridemia; abnormal liver function tests; decreases in hemoglobin, lymphocytes, neutrophils, and platelets)
Ly mphoma and skin cancer
• Ma le infertility
• Menstrual irregularities
Nau sea
• Nephrotoxicity (in combination with cyclosporine)
• Wound healing complications (including wound infections and lymphocele)
There may be other potential adverse events that are unforeseen at this time.
Esprit™ BTK
Everolimus Eluting Resorbable Scaffold System
The Only Device That Does it All for CLTI
•Scaffold to address vessel recoil and dissection 1
•Sustained everolimus elution to inhibit neointimal hyperplasia
•All while leaving nothing behind,3 preserving future treatment options
90.3% OF ESPRIT™ BTK PATIENTS did not require a reintervention through 2 years4,5
SUPERIOR
EFFICACY THROUGH 1 YEAR with sustained benefits through 2 years4,6
BETTER
BTK TREATMENT STARTS HERE
1. Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Instructions for Use (IFU). Refer to IFU for additional information. 2. Data on file at Abbott. 3. Data on file at Abbott. Excluding platinum markers. 4. Brian G. DeRubertis et al., Two-Year Outcomes of the LIFE-BTK Randomized Controlled Trial Evaluating the Esprit™ BTK Drug-eluting Resorbable Scaffold for Treatment of Infrapopliteal Lesions, VIVA 2024. 5. Reintervention defined as CD-TLR. 6. Varcoe, RL., et al. Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease. N Eng J Med 2024;390:9-19.
INDICATIONS
The Esprit™ BT K Everolimus Eluting Resorbable Scaffold System is indicated for improving luminal diameter in infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI) and total scaffolding length up to 170 mm with a reference vessel diameter of ≥ 2.5 mm and ≤ 4.00 mm.
See Important Safety Information on the previous page. Information contained herein for DISTRIBUTION in the U.S. ONLY.
