Aliso Viejo, CA - January 12, 2021 - MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB 17 System, designed with the latest microbraid technology, features a lower profile delivery system compatible with the VIA™ 17 microcatheter and includes additional device configurations.
The WEB System is a unique, single-device treatment solution for wide neck bifurcation aneurysms in a new category of devices called intrasaccular flow disruptors. When placed inside the aneurysm sac, the WEB device's proprietary microbraid technology bridges the aneurysm neck, disrupting blood flow, and creates a scaffold for long-lasting treatment. The WEB System received its first PMA approval in late 2018.
"The excellent clinical results we can achieve with intrasaccular flow disruption technology has changed the way we approach the treatment of wide neck bifurcation aneurysms, and the WEB 17 System expands upon that. Now, we can deliver WEB devices using a low-profile system, similar to those used for standard coil embolization," noted Adam Arthur, MD MPH, Director of Cerebrovascular & Endovascular Neurosurgery at Semmes Murphey Neurologic & Spine Institute, Professor of Neurosurgery at the University of Tennessee, and Principal Investigator of the WEB-IT Pivotal Trial.
"The WEB 17 System has been used to enhance care for thousands of patients globally since its initial launch in 2016. MicroVention is proud to bring this expanded portfolio to physicians in the United States, providing more treatment options for patients with complex aneurysms," said Carsten Schroeder, President and Chief Executive Officer of MicroVention.
For more information regarding the WEB Aneurysm Embolization System, please visit https://www.microvention.com/product/web-family
About Wide Neck Bifurcation Aneurysms
An intracranial aneurysm is a bulging, weak area in the wall of an artery that supplies blood to the brain. A weakness located at a junction between two diverging vessels is called a bifurcation aneurysm.
Important Information About the WEB Aneurysm Embolization System
The WEB System is a unique, single-device treatment solution for wide neck bifurcation aneurysms, which may account for up to 35% of all aneurysms. When placed inside the aneurysm sac, the WEB device's proprietary microbraid technology bridges the aneurysm neck, disrupting blood flow, and creates a scaffold for long-lasting treatment. The pivotal WEB Intrasaccular Therapy Trial (WEB-IT) demonstrated that the WEB System is effective in attaining positive long-term clinical results in a safe, single-device procedure for wide neck bifurcation aneurysms. The WEB Aneurysm Embolization System has been CE marked since 2010 and has been used in more than 12,000 cases and multiple clinical studies throughout the world.
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.
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 sold in more than 75 nations through a direct sales organization alongside strategic distribution partnerships.
Terumo (TSE: 4543) is a global leader in medical technology and has been committed to “Contributing to Society through Healthcare” for 100 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 such as transfusion systems, diabetes care, and peritoneal dialysis treatments. Terumo will further strive to be of value to patients, medical professionals, and society at large.