MicroVention has announced the recently published results of the CLinical EValuation of WEB 17 Device in Intracranial Aneurysms (CLEVER) one year effectiveness results for 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 the CLEVER study demonstrate that the WEB 17 system maintains the same efficacy as previous generations of WEB.
Laurent Spelle (Paris Sud University, Paris, France), a contributor from the CLEVER study made the following comments about the WEB technology and the clinical data supporting it: “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 Spelle.
Adam Arthur (The University of Tennessee Health Science Center, Memphis, USA) principal investigator for the WEB-IT Trial, which was the US investigational device exemption (IDE) study to support WEB premarket approval (PMA) in the USA, also commented: “WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” said Arthur.
“MicroVention’s WEB aneurysm embolization 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 CEO, 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.”
