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.
“The FDA 510k clearance milestone starts a new chapter for Vesalio as it expands our portfolio into additional thrombectomy market segments. In addition, we are pleased to have received a 4th CE approval that expands our neuro-vascular thrombectomy platform,” remarked Steve Rybka, CEO. “Our focus has been on stroke where NeVa is proving to be the market leader in first-pass clot removal. While we remain dedicated to advancements in stroke treatment globally, we are also employing our core technology competency to extend our therapeutic footprint.”
Vesalio’s 4th CE mark will expand its NeVa portfolio of approved neuro-thrombectomy designs to include a 5.5 mm diameter with 3 Drop Zones. “The new 5.5 mm size enhances our offering and strengthens NeVa’s growing prominence in high-clot-burden ICA occlusions. It is extremely gratifying to receive feedback from interventionalists on their successful procedures, especially in the more challenging cases where first-pass recanalization is harder to achieve with more conventional technologies.” commented Diane Demet Tangun, VP Market Development.
Founded in 2013, Vesalio is a privately held medical device company focused on advancing patient care in vascular occlusion by providing physicians superior technology designed to improve clinical outcomes. The Company’s proprietary NeVa™ platform was designed to consistently achieve first-pass recanalization in acute ischemic stroke by effectively removingall types of neurovascular clots from patient anatomy.