Effectiveness of MicroVention’s WEB™ 17 Device in treating intracranial aneurysms has been demonstrated in the recently published results of the CLinical EValuation of WEB 17 Device in Intracranial Aneurysms (CLEVER) study. The global neurovascular company and wholly owned subsidiary of Terumo Corporation announced these findings alongside celebrating the five-year anniversary of its WEB™ Aneurysm Embolization System, which has sold over 10,000 units in the United States.
The CLEVER study, a multicenter, prospective evaluation, focused on the newest and smallest WEB system in both ruptured and unruptured aneurysms. Conducted across 17 European centers, the study included 163 patients and aimed to understand the safety and effectiveness of the WEB 17 system.
Effectiveness of WEB 17 Confirmed: Safe with Low Complication Rates and High Occlusion Success in Aneurysm Treatment
Results concluded that the WEB 17 is as safe and effective as previous generations, with a low complication rate and no rebleeds at 30 days and one year. The study showed an adequate occlusion rate of 86.5% for ruptured aneurysms (73.1% complete occlusion) and 82.4% for unruptured aneurysms (57.1% complete occlusion) at one year follow-up.
“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, a contributor to the study and Professor & Chairman at NEURI Brain Vascular Center, Bicêtre Hospital, APHP, Paris-Saclay University.
The WEB Embolization System is the most well-studied intrasaccular device available in the marketplace, supported by seven good clinical practice (GCP) studies and over 200 peer-reviewed publications. The system offers a single-device solution for wide-neck bifurcation aneurysms, minimizing the need for a dual antiplatelet regimen required for intraluminal therapies. The first-in-class intrasaccular technology of the WEB system underscores MicroVention’s commitment to providing innovative medical device technology with long-term safety and effectiveness.
Effectiveness in Cerebral Aneurysm Treatment: WEB Sets New Safety Standard, Says Dr. Adam Arthur
“WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” stated Dr. Adam Arthur, Principal Investigator for the WEB-IT Trial, which supported WEB PMA approval in the US, and James T Robertson Professor and Chair at The University of Tennessee Health Science Center.
MicroVention is showcasing the WEB system and its entire line of innovative medical device products at the Society of NeuroInterventional Surgery (SNIS 2024) in Colorado Springs. The company’s commitment to advancing patient care through technology is highlighted by its continued collaboration with leading physicians worldwide to address evolving needs in patient care.
Carsten Schroeder, President and CEO of MicroVention, commented: “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. 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 innovative technologies that help to save patient lives.”
The CLEVER study results reinforce the WEB 17 system’s effectiveness in treating wide-neck bifurcation aneurysms, providing a significant advancement in neurovascular care. With its robust clinical data and proven safety profile, the WEB system continues to set new standards in the treatment of intracranial aneurysms, reflecting MicroVention’s dedication to enhancing patient outcomes through pioneering medical technologies.
Resource: Business Wire, July 23, 2024
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