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.
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.
