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Medical Devices / Submissions and Approvals

MicroVention’s Aneurysm Embolization Device Gains Premarket Approval

Jan. 8, 2019

The FDA has given MicroVention’s WEB aneurysm embolization system premarket approval for treating intracranial wide neck bifurcation aneurysms.

The approved device is the only one if its kind in the new category of intravascular flow disruptions for aneurysm embolization.

The single-device treatment uses proprietary microbraid technology to bridge the aneurysm neck and create a long-term scaffold when placed inside the aneurysm sac.

MicroVention is a U.S. subsidiary of Tokyo-based Terumo. The WEB System was developed by Sequent Medical, a company Terumo acquired in 2016.

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