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Vesalio Receives Peripheral FDA 510k Clearance and Additional CE Approval Nashville, TN, January 28, 2021 --(PR.com)-- 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 Zone(TM) 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.”
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