MicroVention Announces Release of CLinical EValuation of WEB™ 17 Device in Intracranial Aneurysms (CLEVER): One Year Effectiveness Results for Ruptured and Unruptured Aneurysms

COLORADO SPRINGS, Colo. & ALISO VIEJO, Calif.--(BUSINESS WIRE)--Jul 23, 2024--

MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, today 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 multicenter, 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.

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MicroVention’s WEB™ Aneurysm Embolization System (Photo: Business Wire)

The study comprised of 163 patients across 17 European centers 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. The WEB is the most well studied intrasaccular device available in the marketplace today, with 7 good clinical practice (GCP) studies and over 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 is also celebrating the five-year anniversary of WEB in the US, showcasing this product and its entire line of innovative medical device products at this year’s Society of NeuroInterventional Surgery (SNIS 2024) in Colorado Springs this week, booth number 521.

Prof. Laurent Spelle, 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 Prof. Laurent Spelle, Professor & Chairman at NEURI Brain Vascular Center, Bicêtre Hospital, APHP, Paris-Saclay University.

Dr. Adam Arthur, Principal Investigator for the WEB-IT Trial, which was the US IDE study to support WEB PMA approval in the US, also commented: “WEB has changed my practice and set a new standard for safety in the treatment of cerebral aneurysms,” said Dr. Adam Arthur, James T Robertson Professor and Chair at The University of Tennessee Health Science Center.

“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, Inc. “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.”

About the WEB Device:

US Indications for use: The WEB Aneurysm Embolization System is indicated for use at the middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex, or basilar artery apex for the endovascular treatment of adult patients with saccular, wide neck bifurcation intracranial aneurysms with dome diameter from 3 mm to 10 mm and either neck size 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.

CE Mark Indication : The WEB Aneurysm Embolization System is intended for the endovascular embolization of ruptured and unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae (AVF). The WEB Aneurysm Embolization System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

The CLEVER study was conducted in the European Union.

Data Reported is based on indications of the countries studied.

About MicroVention, Inc.

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, Japan, acquired MicroVention into their family of Companies. Terumo’s acquisition of MicroVention allowed both Companies to leverage their unique, proprietary technologies toward an increased focus on treating cerebrovascular diseases. Headquartered in California, MicroVention products are today sold in more than seventy countries through a direct sales organization alongside strategic distribution partnerships. Manufacturing facilities are in Aliso Viejo, California and San José, Costa Rica. For more information on MicroVention, please visit www.microvention.com.

About Terumo Corporation

Terumo (TSE:4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for one hundred years. Based in Tokyo and operating globally, Terumo employs more than 30,000 associates worldwide to provide innovative medical solutions in more than 160 countries and regions. The company started as a Japanese thermometer manufacturer and has been supporting healthcare ever since. Now, its extensive business portfolio ranges from vascular intervention and cardio-surgical solutions, blood transfusion and cell therapy technology, to medical products essential for daily clinical practice. Terumo will further strive to be of value to patients, medical professionals, and society at large.

** Editor’s Note: For a Clinical Glossary of Terms, please visit https://www.microvention.com/clinical-education/glossary.

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CONTACT: Christine McCullough

Global Corporate Communications

MicroVention, Inc.

+ 1 714 206 9800

christine.mccullough@microvention.com

KEYWORD: UNITED STATES JAPAN NORTH AMERICA ASIA PACIFIC CALIFORNIA COLORADO

INDUSTRY KEYWORD: SCIENCE BIOTECHNOLOGY RESEARCH GENERAL HEALTH HEALTH MEDICAL DEVICES HEALTH TECHNOLOGY OTHER HEALTH

SOURCE: MicroVention, Inc.

PUB: 07/23/2024 09:00 AM/DISC: 07/23/2024 09:01 AM

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