s THE D nes N O PAre EDITI a w NTH A MO
In this issue:
8 T he Outpatient Comparing office practice models: Should we joint venture?
2G uest editorial Unionization: Vascular surgeons, are you ready to join forces?
12 Complex PAD Advances in endovascular therapy help drive innovative CPVI course
4S WEDEPAD Paclitaxel debate re-opens as findings show drug-coated devices don’t improve outcomes
SEPTEMBER 2025 Volume 21 Number 8
THE OFFICIAL NEWSPAPER OF THE
www.vascularspecialistonline.com
NO-OPTION CLTI
Enduring PROMISE: Realworld outcomes study suggests results continue to flow from transcatheter arterialization of the deep veins
SVS HIGHWAY TO HEALTH CAMPAIGN AIMS TO MAKE PAD A HOUSEHOLD TERM By Marlén Gomez
THE FOOD AND DRUG ADMINISTRATION (FDA) HAS ISSUED A letter to enVVeno Medical stating that its VenoValve device is “notapprovable,” a company press release reported in late August. The letter was issued in response to enVVeno’s premarket approval (PMA) application for the technology—a surgical replacement venous valve in cases of severe deep chronic venous insufficiency (CVI). According to enVVeno, the letter indicates that the FDA completed
THE SOCIETY FOR VASCULAR Surgery (SVS) is ramping up its national Highway to Health campaign to educate the public about peripheral arterial disease (PAD) and the importance of early detection as part of September’s PAD Awareness Month. Anahita Dua, MD, a vascular surgeon at Massachusetts General Hospital and a spokesperson for the campaign, said the initiative is rooted in changing how people think about vascular health. “PAD, if left untreated, can have complications similar to a heart attack or stroke,” said Dua. “It’s the same disease process—blocked arteries—but in the legs. And that means it’s just as serious.” PAD affects millions of Americans, yet public awareness remains low. The Highway to Health campaign aims to close that gap through media outreach, educational resources and community events. The campaign’s website, YourVascularHealth.org, offers symptom checklists, videos, patient toolkits and guidance on finding vascular specialists. “If you stop someone on the street and ask what a heart attack is, they know. Ask about PAD, and they have no idea,” said Dua. “That’s the problem. We talk to patients about amputation, but we don’t explain the disease itself.” This lack of awareness leads to delayed diagnoses and missed opportunities for early intervention, according to Dua, who believes that community education is the key.“We need a national message where people understand PAD. If someone has crampy pain in their leg, they should think, ‘Maybe it’s PAD,’ and know to call their doctor.” In August, the campaign generated 2.7 billion media
See page 3
See page 3
First retrospective analysis shows comparable outcomes data to those found in PROMISE II pivotal trial, authors report.
the same time points. The data were revealed during the 2025 annual meeting of the Eastern Vascular Society (EVS) in Nashville (Sept. 4–7) by presenting author Yana Etkin, MD, associate chief of vascular and endovascular surgery in the Zucker School of Medicine at Hofstra/Northwell. Etkin pointed to six-month results from PROMISE II showing a limb salvage rate of 76%, survival of 87.1% and amputation-free survival of 66.1%. “This first real-world, multicenter retrospective study of LimFlow showed outcomes consistent with PROMISE II,” she told those gathered at EVS 2025. “[TADV] achieves favorable outcomes with a high rate of limb salvage up to one year.” In an interview with Vascular Specialist ahead of presenting the data, Etkin spoke of the device’s role in the fight against diabetes-driven peripheral arterial disease (PAD) across the U.S. “PAD is on rise in the U.S., specifically because of the really high rates of diabetes,” she says. “Every 11th person in our country has diabetes—that is now the no. 1 risk for PAD—and almost 4 million people have PAD. So, the rate of limb loss con-
By Bryan Kay
T
he first post-approval multicenter analysis of so-called “no-option” chronic limb-threatening ischemia (CLTI) patients treated using a pioneering transcatheter arterialization of the deep veins (TADV) device lays out a set of real-world outcomes that align with those achieved in the PROMISE II pivotal trial of the device, the authors report. Researchers from Northwell Health in New Hyde Park, New York, MedStar Health in Washington, D.C., and UT Southwestern in Dallas revealed limb salvage rates of 76.1% at six months and 71.7% at one year, respectively, among an 80-patient cohort with a median follow-up of 184 days after TADV (LimFlow, acquired by Inari Medical, now part of Stryker). Furthermore, the study showed survival of 93.1% and 84.7% at six months and one year, respectively. Likewise, the research team reported amputation-free survival rates of 74.2% and 63.6% at
See page 4
FDA DEEMS ENVVENO’S VENOVALVE ‘NOT-APPROVABLE’
Vascular Specialist 9400 W. Higgins Road, Suite 315 Rosemont, IL 60018
IM
PAID
CHANGE SERVICE REQUESTED
PRESORTED STANDARD MAIL U.S. POSTAGE