50 Featured in this issue:
MR CLEAN-LATE results published in The Lancet page 5
WEB 17 device maintains efficacy, safety across ruptured and unruptured aneurysms The Woven EndoBridge (WEB) 17 device (Microvention/Terumo Corporation) has demonstrated positive efficacy and safety outcomes in the prospective, multicentre CLEVER study, indicating its utility for intrasaccular embolisation across ruptured and unruptured intracranial aneurysms. Twelve-month results from the study were delivered by Laurent Spelle (Bicêtre Hospital, Paris, France) at the LINNC Americas Seminar (16–17 March, Miami, USA).
www.neuronewsinternational.com
Profile J Mocco
Measuring success in stroke thrombectomy David S Liebeskind
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RATE OF MAJOR STROKE
Moving on to discuss the study’s primary efficacy endpoint— ultimately assessed in 146 patients—Spelle reported an 82.2% rate of target aneurysm adequate occlusion (complete occlusion he CLEVER study was set up to assess whether—despite or neck remnant) without retreatment at one year. Regarding its lower profile in comparison to prior device iterations— secondary efficacy outcomes, he stated that four of 152 patients the newer-generation WEB 17 system maintains (2.6%) required retreatments at 12 months, and pointed to efficacy and safety in the treatment of bifurcation complete occlusion (62.9%) and neck remnant aneurysms, Spelle reported. It was conducted at 17 (21%) rates on the three-grade Raymond-Roy clinical sites spanning Finland, France, Germany, occlusion classification (RROC) scale, resulting in Hungary and the UK, with Spelle being one of three an 83.9% adequate occlusion rate when allowing trial coordinators alongside Christophe Cognard for retreated aneurysms. (Toulouse University Hospital, Toulouse, France) and Finally, the speaker relayed 73.1% complete István Szikora (National Institute of Mental Health, occlusion and 86.6% adequate occlusion rates as per Neurology and Neurosurgery, Budapest, Hungary). RROC, and one retreatment, in the study’s ruptured Laurent Spelle aneurysm subgroup. Spelle then drew comparisons A total of 163 patients (mean age 58.1 years, 68% female) including 103 with unruptured aneurysms and 60 with between CLEVER and the CLARYS study, which assessed ruptured aneurysms, none of which had previously been treated, the original, larger WEB device in ruptured aneurysms. He were enrolled from June 2019 to February 2021. CLEVER’s concluded that, “along its evolution, the WEB device remains primary safety endpoint was death of non-accidental cause/any safe and efficient” in such cases, citing similar maximum major stroke ≤30 days after treatment, or death/major ipsilateral aneurysm sac widths in CLARYS and CLEVER’s ruptured stroke of neurologic cause from day 31 to one year after subgroup, as well as lower rates of morbidity and mortality treatment. Its primary efficacy endpoint—evaluated at James observed in the latter patient cohort.
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New trial seeks “thorough understanding” of VNS response in depression page 25
Byrne’s (University of Oxford, Oxford, UK) core lab—was adequate occlusion without retreatment at one year. Outlining the study results, Spelle highlighted that there were no treatment failures with WEB 17 across all 163 aneurysms, while adjunctive devices—primarily balloons—were required in just nine unruptured (8.7%) and seven ruptured (11.7%) cases. Based on clinical event adjudication, CLEVER met its key safety endpoint, with three patients (1.8%) suffering a major stroke and zero deaths due to a neurologic cause occurring within one year post-treatment. Touching on the study’s secondary safety endpoints, Spelle also noted a 2% rate of morbidity (defined as modified Rankin scale [mRS] >2) and a 0.6% overall mortality rate at 12 months, as well as one perioperative bleeding event and no rebleeding in patients with ruptured aneurysms, and one haemorrhagic complication in patients with unruptured aneurysms. He further detailed that none of the haemorrhagic complications seen within one year had any clinical consequences, and that no WEB-related morbidity or mortality was observed.
ADEQUATE OCCLUSION RATE (WITH RETREATMENT)
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June 2023 |
Stryker completes acquisition of Cerus Endovascular STRYKER HAS ANNOUNCED the completed acquisition of Cerus Endovascular—a medical device company engaged in the design and development of neurointerventional devices for the treatment of intracranial aneurysms. In an announcement released on 2 May confirming this acquisition, Stryker claimed that technology for the endovascular treatment of aneurysms has been “foundational” to the company’s neurovascular division, and that Cerus’ portfolio will “address the growing need for one-and-done intrasaccular aneurysm therapy”. Cerus’ CE-marked products include the intrasaccular Contour neurovascular system and the adjunctive Neqstent coil-assisted flow diverter, both of which gained European clearance for the treatment of intracranial aneurysm in 2020. The company’s Contour device also received a green light from the US Food and Drug administration (FDA) in 2021—initially in the form of a Breakthrough Device designation in February, and subsequently via an investigational device exemption (IDE) study approval in April. As per a press release, acquisition of these products will help to expand Stryker’s current haemorrhagic stroke portfolio, which currently includes the Target family of detachable embolisation coils; Surpass Streamline and Surpass Evolve flow diverters; and Neuroform Atlas stent system.