April 18, 2019
Aliso Viejo, CA - April 18, 2019 - MicroVention, Inc., a U.S.-based subsidiary of Terumo Corporation and a global neurovascular company, announced today the publication of the WEB-IT pivotal trial results in the online edition of the Journal of NeuroInterventional Surgery.
The WEB® Aneurysm Embolization System met its primary safety and effectiveness endpoints in this prospective, single-arm study of 150 patients conducted at 21 U.S. and 6 international centers. The results of the study led to the Premarket Approval (PMA) of the WEB® System late last year by the Food and Drug Administration in the United States for treatment of wide neck bifurcation aneurysms in the brain.
"The WEB-IT pivotal trial shows that the WEB® System is an effective and extremely safe treatment for a subset of aneurysms that are challenging to treat with standard embolization coils and assist devices. None of the aneurysms treated with the WEB® System in the trial had follow-up bleeding events," stated Adam Arthur, M.D., Director of Cerebrovascular & Endovascular Neurosurgery at Semmes Murphey Neurologic & Spine Institute, Associate Professor of Neurosurgery at University of Tennessee, and a Principal Investigator of the WEB-IT Trial.
The WEB® system provides a clinically-proven, single device treatment option that advances the treatment of up to 35% of all brain aneurysms. The System's proprietary microbraid technology bridges the aneurysm neck to disrupt blood flow and creates a scaffold for a long-lasting effect. The WEB® System has been CE marked since 2010 with more than 6,000 cases performed throughout the world.
"The results of the WEB-IT trial match the patient outcomes we've seen in the six other good clinical practice studies completed in Europe. I have seen the positive impact of this device in my clinical practice since it became available. The WEB provides a very safe and minimally invasive treatment option for many patients who might have otherwise required open surgical clipping of their aneurysm." said David Fiorella, MD, PhD, Professor of Neurological Surgery and Radiology, Director of Neurointerventional Radiology, Stony Brook University Cerebrovascular and Stroke Center and a Principal Investigator of the WEB-IT Trial.
For more information regarding the WEB Aneurysm Embolization System, please visit www.microvention.com.
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.
This device 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.
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 its 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.
Founded in 1921, Tokyo-based Terumo Corporation is one of the world's leading medical device manufacturers with operations in more than 160 nations. Terumo develops, manufactures and distributes world-class medical devices, including products for use in cardiothoracic surgery, interventional procedures and transfusion medicine. It also manufactures a broad array of syringe and hypodermic needle products for hospital and physician office use.
Terumo contributes to society by providing valued products and services to the health care market and by responding to the needs of health care providers and the people they serve. Terumo Corporation's shares are listed on the first section of the Tokyo Stock Exchange (No. 4543, Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a component of the Nikkei 225, Japan's leading stock index.
(Notice) Among the information that Terumo discloses, the forward-looking statements including financial projections are based upon our assumptions using information available to us at the time and are not intended to be guarantees of future events or performance. Accordingly, it should be noted that actual results may differ from those forecasts on projections due to various factors. Factors affecting to actual results include, but are not limited to, changes in economic conditions surrounding Terumo, fluctuations of foreign exchange rates, and state of competition. The market share information in this press release is partly derived from our own independent research.