FDA Approves MicroVention's Web Intrasaccular Aneurysm Embolization System
January 7, 2019—MicroVention, Inc., a United States–based subsidiary of Terumo, announced FDA premarket approval for its Web aneurysm embolization system for the treatment of intracranial wide-neck bifurcation aneurysms. The Web system is an intrasaccular flow disruptor for aneurysm embolization. The device was developed by Sequent Medical, Inc., which was acquired by Terumo in 2016.
The Web system is a single-device treatment solution for wide-neck bifurcation aneurysms. When placed inside the aneurysm sac, the device's microbraid technology bridges the aneurysm neck, disrupting blood flow, and creates a scaffold for long-lasting treatment.
This device 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 diameters of 3 to 10 mm and either neck size ≥ 4 mm or a dome-to-neck ratio > 1 and < 2.
The pivotal Web Intrasaccular Therapy (WEB-IT) trial, which enrolled 150 patients at 31 sites in the United States, Canada, and Europe, demonstrated that the Web system is effective in attaining positive long-term clinical results. The Web aneurysm embolization system received European CE Mark approval in 2010.
WEB-IT Principal Investigator Adam Arthur, MD, commented in the company's announcement, "The Web system provides a valuable alternative for the treatment of bifurcation aneurysms. In the WEB-IT pivotal trial, the Web system demonstrated 84.6% adequate occlusion and an extraordinary safety profile for a subset of aneurysms that are challenging to treat with standard embolization coils and assist device."
David Fiorella, MD, also a Principal Investigator of the WEB-IT trial, added, "In the pivotal trial, patients benefited from the Web system through a safe and effective treatment with excellent clinical outcomes, fast procedure times, and limited radiation exposure. The Web system is a first-to-market, innovative, and highly studied intrasaccular solution that advances the treatment of wide neck bifurcation aneurysms."