Vesalio has announced in a company press release that it has received 510(k) clearance from the US Food and Drug Administration (FDA) and its fourth CE mark.
According to Vesalio, the FDA 510(k) indication is for the removal of thrombi in peripheral blood vessels and the CE approval expands the NeVa neuro-thrombectomy portfolio. The press release further states that Vesalio’s fourth CE mark will expand its NeVa portfolio of approved neuro-thrombectomy designs to include a 5.5 mm diameter with three Drop Zones.
The company states that the Vesalio’s Drop Zone 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 510(k) 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 fourth CE approval that expands our neuro-vascular thrombectomy platform,” said Steve Rybka, CEO of Vesalio, San Diego, USA. “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.”
“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 recanalisation is harder to achieve with more conventional technologies,” commented Diane Demet Tangun, VP of market development at Vesalio, San Diego, USA.