Cerus Endovascular, a privately held, commercial-stage medical device company, has received U.S. FDA 510(k) clearance for its 027 microcatheter.
This clearance expands its product portfolio which includes the already FDA cleared 021 microcatheter platform. The company expects to submit for CE Marking of both sizes under the EU new Medical Devices Regulation, later this year.
“Our focus on continually meeting the demands of the clinical and physician communities, including interventional radiologists, with timely, value-added products, is evidenced by this latest FDA approval for the 027 microcatheter, for which sales will commence shortly, both domestically and internationally,” says Stephen Griffin, PhD, president of Cerus Endovascular.
A limited U.S. market release of the 027 microcatheter, which is available in two lengths, is expected to begin in the second quarter of 2022, with the 021 microcatheter platform to follow shortly thereafter.
“Our development work has demonstrated the superior characteristics of our micro-catheters, in comparison to currently commercially available devices and we look forward to their more broad-based usage,” says Jeff Sarge, vice president of Research & Development at Cerus Endovascular. “Importantly, the micro-catheters are not limited to supporting just the Cerus Endovascular Contour Neurovascular System and Neqstent family of products but can also be used by any other company devices which are compatible with 021 and 027 micro-catheters.”
