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PRESS RELEASE

Vesalio Receives Peripheral FDA 510k Clearance and Additional CE Approval

Nashville, TN, January 28, 2021 Vesalio reports it has obtained an FDA 510k clearance and its 4th CE approval.  The FDA 510k indication is for the removal of thrombi in peripheral blood vessels. The new CE approval expands the NeVa™ neuro-thrombectomy portfolio. Vesalio’s Drop ZoneTM technology, designed to remove the full spectrum of clots from vascular anatomy, has been acclaimed for consistently achieving high first-pass rates, a key parameter associated with better patient outcomes in stroke.

PRESS RELEASE

Lower-Profile Web Intrasaccular aneurysm treatment device receives FDA a...

Aliso Viejo, CA. – January 12, 2021 – MicroVention, Inc., a U.S.-based subsidiary of Terumo and a global neurovascular company, announced today 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.

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