Microvention, a wholly owned subsidiary of Terumo Corporation, has announced the recent publication in the Journal of NeuroInterventional Surgery (JNIS) of one-year results from CLEVER—a study that sought to provide a clinical evaluation with the Woven EndoBridge (WEB) 17 device in treating ruptured and unruptured aneurysms.
The CLEVER study was a multicentre, prospective study evaluating the WEB 17 system in ruptured and unruptured aneurysms to understand the safety and effectiveness of the newest and smallest WEB system.
The study comprised of 163 patients across 17 European centres, with results concluding that WEB 17 is just as safe and effective as previous WEB generations with a low complication rate, and no rebleeds at 30 days and one year. The adequate occlusion rate was 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion) at one-year follow-up.
The results of CLEVER demonstrate that the WEB 17 system maintains the same efficacy as previous generations of WEB, a company press release reiterates.
WEB is the most well-studied intrasaccular device available on the marketplace today, with seven good clinical practice (GCP) studies and more than 200 peer-reviewed publications, according to Microvention. It is described by the company as a first-in-class intrasaccular technology offering a single-device solution for wide-neck bifurcation aneurysms that minimises the need for a dual antiplatelet regimen required for intraluminal therapies.
“One-year angiographic results of CLEVER show excellent complete occlusion rates at one year in the population of wide-neck bifurcation aneurysms treated with WEB 17,” said Laurent Spelle (Bicêtre Hospital, Le Kremlin-Bicêtre, France), a leading author for the recent publication of CLEVER in JNIS.
“WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” added Adam Arthur (University of Tennessee Health Science Center, Memphis, USA), principal investigator for the WEB-IT Trial—which was the investigational device exemption (IDE) study supporting WEB’s post-market approval (PMA) in the USA.
Microvention is also currently celebrating the five-year anniversary of WEB in the USA, showcasing this product and its entire line of innovative medical device products at the 2024 Society of NeuroInterventional Surgery (SNIS) annual meeting (22–26 July, Colorado Springs, USA).
“Microvention’s WEB aneurysm embolisation system is now the most studied intrasaccular device available today, underscoring our commitment to physicians and patients alike to provide innovative, advanced medical device technology coupled with long-term safety and effectiveness,” said Carsten Schroeder, president and chief executive officer at Microvention. “With over 10,000 units sold in the USA, WEB advances treatment of wide-neck bifurcation aneurysms with one intrasaccular device—clinically proven ‘one and done’ treatment. We will continue to work side-by-side with leading physicians around the world to identify the evolving needs in patient care, and then transform those insights into innovative technologies that help to save patient lives.”
