Cerus Endovascular has received US Food and Drug Administration (FDA) 510(k) clearance for its 027 microcatheters, available in two lengths, expanding on a product portfolio that includes the already FDA-cleared 021 microcatheter platform.
The company now expects to submit for CE marking of both sizes under the new European Union (EU) Medical Devices Regulation later this year—while a limited US market release of the 027 microcatheters is expected to begin in the second quarter of 2022, with the 021 microcatheters platform to follow shortly thereafter.
“Today’s therapeutic devices place more demands on a delivery system, and we have developed a microcatheter platform designed to provide exceptional support and stability when delivering these devices within the neurovasculature,” said Jeff Sarge, vice president of Research and Development at Cerus.
The company also recently announced that it is expanding the size offerings of its Contour neurovascular system platform. The newer additional sizes, currently in development (3mm, 18mm and 22mm), will allow for the treatment of aneurysms up to 18mm in diameter, according to a Cerus press release.
“Upon approval, these larger sizes, in particular, will meet an unmet clinical need for treating aneurysms 80% larger than current commercially available endosaccular solutions,” said Cerus president Stephen Griffin. “Our work is progressing as planned and we look forward to making these new sizes commercially available as soon as possible.”