Cerus Endovascular this week announced the FDA 510(k) clearance of its 027 microcatheters.
Fremont, California-based Cerus Endocascular’s new microcatheters are available in two lengths. The company expects to submit for CE mark approval under the EU new Medical Devices Regulation later this year.
A limited market release of the 027 microcatheters in the U.S. is expected to begin in the second quarter of 2022, with Cerus Endovascular’s 021 microcatheters platform to follow.
“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 micro-catheters, for which sales will commence shortly, both domestically and internationally,” Cerus Endovascular President Stephen Griffin said in a news release.
With the announcement of the clearance, the company said it is expanding the size offerings of its Contour Neurovascular System platform. The new sizes, 3 mm, 18 mm and 22 mm, are currently in development and will allow for the treatment of aneurysms up to 18 mm in diameter.
“The continued expansion of our portfolio and the increased market penetration are key elements of our ongoing commercialization strategy,” Cerus Endovascular Chair Sam Milstein said in the news release. “The company’s commercial footprint now extends to over 330 clinical centers, worldwide, and will shortly be expanding further into Asia and launching in Central and South America. Enrollment in the Cerus Endovascular IDE trial in the United States continues as scheduled.”