FDA Approves MicroVention’s Lower-Profile WEB 17 Intrasaccular Aneurysm Treatment Device

January 12, 2021—MicroVention, Inc., a United States-based subsidiary of Terumo, announced FDA approval of the premarket approval application supplement for the company’s Woven EndoBridge (WEB) 17 system, a new addition to the WEB aneurysm embolization system for the treatment of intracranial wide-neck bifurcation aneurysms.

According to the company, the WEB 17 system is designed with microbraid technology, features a lower-profile delivery system compatible with the Via 17 microcatheter, and includes additional device configurations.

“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,” commented Adam Arthur, MD, in MicroVention’s announcement. “Now, we can deliver WEB devices using a low-profile system, similar to those used for standard coil embolization.”

Dr. Arthur, who is Principal Investigator of the WEB-IT pivotal trial, is Director of Cerebrovascular & Endovascular Neurosurgery at Semmes Murphey Neurologic & Spine Institute and Professor of Neurosurgery at the University of Tennessee in Memphis, Tennessee. In April 2019, Dr. Arthur et al published the final 12-month results of the WEB-IT trial in Journal of NeuroInterventional Surgery (2019;11:924-930).

MicroVention stated that when placed inside the aneurysm sac, the WEB device’s microbraid technology bridges the aneurysm neck (disrupting blood flow) and creates a scaffold for long-lasting treatment. The WEB system received its first FDA approval in late 2018.

The WEB aneurysm embolization system is indicated for use at the middle cerebral artery bifurcation, internal carotid artery terminus, anterior communicating artery complex, or basilar artery apex for the endovascular treatment of adult patients with saccular, wide neck, bifurcation intracranial aneurysms with dome diameter from 3 to 10 mm, and either neck size ≥ 4 mm or dome-to-neck ratio > 1 and < 2, advised MicroVention.