MicroVention Announces 5-Year Clinical Trial Data and Size Additions for its WEB Aneurysm Embolization System; WEB is Most Well-Studied Intrasaccular Device Available Today

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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.

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Monday, July 31, 2023

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UNITED STATES, NORTH AMERICA, CALIFORNIA

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TERUMO, MICROVENTION, MICROVENTION, INC., TERUMO CORPORATION

Summary

Key Points:

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.
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.
At this time, there is no device that has been shown to be safer for aneurysm patients than WEB.

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.

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

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-IT ¹	WEBCAST 1&2²	CLARYS^3,4*	CLEVER^5*
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)
Bleed/Rebleed	0%	0%	0%	0%
Overall Morbidity	n/a	1.0%	9.6%	2.0%
Overall Mortality	4.7%	7.0%	3.8%	0.6%

Not included: FROBS, WEB-IT China

* CLEVER and CLARYS were conducted in accordance with EU indications for use. Occlusion and safety findings do not necessarily correlate with WEB results in other geographies.

1. Fiorella D, Molyneux A, Coon A, et al. Safety and effectiveness of the Woven EndoBridge (WEB) system for the treatment of wide necked bifurcation aneurysms: final 5 year results of the pivotal WEB Intra-saccular Therapy study (WEB-IT). J Neurointerv Surg 2023.

2. Pierot L, Szikora I, Barreau X, et al. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up. J Neurointerv Surg. 2022.

3. Spelle L, Herbreteau D, Caroff J, et al. Clinical Assessment of WEB device in Ruptured aneurysms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study. J Neurointerv Surg. 2022;14(8):807-814.

4. Spelle, L., et al. (2022) “Clinical Assessment of WEB device in Ruptured Aneurysms (CLARYS): 12-month angiographic results of a multicenter study. J NeuroIntervent Surg

5. CLEVER: Clinical evaluation of WEB 0.017 device in intracranial aneurysms. Final results at 1 year. Observational post-market, prospective, multicenter GCP study. Conducted at 17 European sites with a minimum of 160 subjects. Data comes from information presented at ISC 2023.

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 28,000 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. For more information on Terumo, please visit www.terumo.com/about/profile.

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

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