Perceval Sutureless Heart Valve approved by FDA for replacement of diseased or damaged aortic valves- LivaNova

LivaNova has received approval from the FDA for the Perceval Sutureless Heart Valve. The approval is effective immediately, and the Company will begin commercial distribution of the device in the US over the coming quarter.

Comment: There is a debate comparing sutureless surgical aortic valve replacements such as Perceval and transcatheter aortic valve replacements (such as Core valve and Sapien XT) which are used for patients too frail for open heart surgery. The Perceval requires open heart surgery for implantation but self-anchors and does not require sutures, distinguishing it from Medtronic's 3f Aortic Bioprosthesis and the CE-Marked Intuity Elite from Edwards.