San Diedo and Aliso Viejo, California – July 31, 2023 – MicroVention, Inc., a global neurovascular company and wholly owned subsidiary of Terumo Corporation, announced the publication of WEB-IT 5-year follow-up data and the addition of two sizes to its WEB Aneurysm Embolization System. With this five-year clinical trial data just recently published, 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. WEB is also now available in two new sizes (SL 6x2 and SL 7x2), continuing to allow for the treatment of different sizes and shapes of aneurysms. MicroVention is showcasing this product and its entire line of innovative medical device products at this year’s Society of NeuroInterventional Surgery (SNIS 2023) in San Diego this week, booth number 615.
The WEB device is designed to treat brain aneurysms inside the aneurysm sac – disrupting blood flow, while sealing the neck and protecting the dome with MicroVention’s MicroBraid™ Technology. Additionally, the WEB device provides proven, long-term durability with its five-year follow-up results demonstrating long-term safety and effectiveness and is the only 17-system compatible intrasaccular flow disruptor.
MicroVention’s WEB System overcomes the challenges of multiple devices in treating wide-neck bifurcation aneurysms:
• Reduces procedure times with a single device solution and less radiation exposure.
• Provides robust scaffold for endothelialization.
• Provides flexibility with the ability to resheath, reposition and retrieve device.
The two Principal Investigators from the WEB-IT trial made the following comments about the WEB technology and the clinical data supporting it:
“From the GCP studies, there is currently a total of 1464 patient-years and counting, from 601 patients, during which no patient has experienced bleeding or re-bleeding from a WEB-treated aneurysm – a remarkable track record of effectiveness over a large, accumulated experience,” said Dr. David J. Fiorella, Director of the Stony Brook Cerebrovascular Center, Co-Director of the Stony Brook Cerebrovascular and Comprehensive Stroke Center, and Professor of Neurosurgery and Radiology.
“It is great to have long term follow up on this large, adjudicated GCP study. At this time, there is no device that has been shown to be safer for aneurysm patients than WEB. So, if a patient with a wide-neck bifurcation aneurysm can be treated with WEB, that ought to be the primary consideration,” 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 proven by long-term clinical safety and efficacy data,” said Carsten Schroeder, President and CEO, MicroVention, Inc. “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.”
MicroVention WEB Aneurysm Embolization System – Five Year Clinical Trial Data
7 Good Clinical Practice (GCP) Studies and More Than 200 Publications
|WEB GCP Studies||WEB-IT1||WEBCAST 1&22||CLARYS3,4*||CLEVER5*|
|Study Description||US IDE - long-term follow-up||European long-term follow-up||European study of WEB in ruptured aneurysms||European study of WEB 17-system|
|Study Design||Prospective, multicenter, single-arm, core lab adjudicated||Prospective, multicenter, single-arm, core lab adjudicated||Prospective, multicenter, single-arm, core lab adjudicated||Prospective, multicenter, single-arm, core lab adjudicated|
|Number of Aneurysms||150||95||60||163|
|Angiographic Follow-up||5 years||5 years||1 year||1 year|
|Ruptured aneurysms treated||6.0% (9/150)||7.4% (7/95)||100% (60/60)||26.8% (60/163)|
|Complete and Near Complete Occlusion||87.2% (129/148)||77.9% (74/95)||87.0% (40/46)||83.9% (120/143)|
Not included: FROBS, WEB-IT China
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.