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.