FDA approves CROWN PRT stented aortic bioprosthesis for aortic valve disease.-LivaNova

LivaNova PLC (formerly Sorin Group) announced it has been granted approval from the FDA for its innovative stented aortic bioprosthesis CROWN PRT for the treatment of aortic valve disease. This is the second valve to be approved in the U.S. from LivaNova this year and is expected to be launched in the coming months. LivaNova�s Perceval valve, the sutureless biological valve on the market for aortic valve replacement procedures, was approved on January 8, 2016.

Comment: The stented aortic bioprosthesis spares patients the discomfort of lifelong oral anticoagulation therapy while providing a durable, surgeon-friendly design, PRT technology and excellent hemodynamic performance. The Crown PRT uses visible markers to ease implantation and improve X-ray visualization, and has a short rinse time, enabling intraoperative handling. Sorin says research has shown that phospholipid reduction treatment decreases the phospholipid content in pericardial tissue, known to calcify bioprotheses, leading to a significant reduction of calcium uptake compared with control. CROWN PRT is an ideal aortic valve replacement option for older patients.

CE mark was granted for the device in 2014.