Study: MicroVention’s WEB 17 System Just as Safe, Effective as Previous Versions

MicroVention Inc. is spotlighting published study results proving the efficacy of its WEB 17 system.

Data from the CLinical EValuation of WEB 17 Device in Intracranial Aneurysms (CLEVER) trial showed the WEB 17’s efficacy is equivalent to previous versions of the device. The study evaluated the WEB 17 system in ruptured and unruptured aneurysms to better understand its safety and efficacy. 

“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 Prof. Laurent Spelle, professor and chairman at NEURI Brain Vascular Center, Bicêtre Hospital, APHP, Paris-Saclay University, and CLEVER study contributor.  

Comprised of 163 patients across 17 European centers, the trial found 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 CLEVER study results show the WEB 17 system maintains the same efficacy as previous generations of WEB.

“WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” stated Dr. Adam Arthur, a James T. Robertson professor and chair at The University of Tennessee Health Science Center. He also was the principal investigator for the WEB-IT Trial, which was the U.S. Investigational Device Exemption study to support WEB PMA approval in the United States.

 

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READ MORE: Terumo’s MicroVention Releases 5-Year WEB Aneurysm Embolization System Data

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The WEB reportedly is the most well-studied intrasaccular device currently available in the marketplace, with seven good clinical practice (GCP) studies and more than 200 peer-reviewed publications. The WEB Embolization System is first-in-class intrasaccular technology offering a single-device solution for wide-neck bifurcation aneurysms. The intrasaccular embolization system minimizes the need for a dual antiplatelet regimen required for intraluminal therapies. 
 
“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,” MicroVention President/CEO Carsten Schroeder added. “With over 10,000 units sold in the United States, 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 technologies that help to save patient lives.” 
 
The CLEVER study was conducted in the European Union.      
 
Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. In 2006, Terumo Corporation, a major worldwide medical device company headquartered in Tokyo, acquired MicroVention. Terumo’s acquisition of MicroVention allowed both companies to leverage their proprietary technologies toward an increased focus on treating cerebrovascular diseases. Headquartered in California, MicroVention products are sold in more than 70 countries through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, Calif., and San José, Costa Rica.  
 
Terumo is a global leader in medical technology and employs more than 30,000 associates worldwide to provide medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Its business portfolio currently ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice.