California-based Reverse Medical landed key FDA approval to launch U.S. clinical trials of its Barrel vascular reconstruction device for treatment of intracranial bifurcation aneurysms.
The company plans to finalize its trial structure "very soon" and begin enrolling patients within the next few months, president & CEO Jeffrey Valko said in prepared remarks.
The privately held company won European CE Mark approval late last year for the Barrel device, adding to a string of recent regulatory wins.
In February Reverse won E.U. approval for its UNO neurovascular embolization system and in December the company won FDA clearance for its MVP-5 micro vascular plug.
The company has been announcing regulatory wins nearly every 2 months, with E.U. and U.S. nods in October for its ReVerse 21 and 27 neurovascular microcatheters and FDA clearance in August for its MVP micro vascular plug.
