Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval

MicroVention, a U.S.-based subsidiary of Terumo, announced 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 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," said Adam Arthur, M.D. 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.

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.