Reverse Medical lands CE Mark, 510(k) for brain catheters

October 31, 2013 by Chris Walker

Reverse Medical lands CE Mark approval in Europe and a 510(k) nod from the FDA for its ReVerse 21 and 27 neurovascular microcatheters.

Reverse Medical Corp. wins CE Mark approval and FDA 510K clearance

Reverse Medical Corp. said it won CE Mark approval in the European Union and 510(k) clearance from the FDA for its ReVerse neurovascular microcatheter device.

The regulatory nods are for use in the neurological, peripheral and coronary vasculature for the infusion of diagnostic and therapeutic agents, according to a press release.

"Building on our expertise and proprietary know-how from our intracranial distal access catheter success, we identified an unmet need for a microcatheter designed specifically for delivery of new, complex therapeutic devices. The ReVerse microcatheter incorporates proprietary inner lumen friction reducing and strengthening technology and is designed to facilitate predictable, low friction state-of-the-art device delivery," CTO Brian Strauss said in prepared remarks.

Sign up to get our free newsletters delivered straight to your inbox

In August, Reverse Medical won 510(k) clearance from the FDA for its MVP micro vascular plug, after winning CE Mark approval for the device in Europe.