CE mark approval for Perceval sutureless aortic valve extended age indication


Sorin Group announced Perceval, its sutureless aortic valve has received CE mark approval for adult age indication allowing treatment of a wider spectrum of patients with aortic stenosis and/or steno-insufficiency. Until now, only patients over 65 years of age could benefit from the Perceval technology.

Perceval is a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery. According to Sorin, implant with Perceval is easy, safe and reproducible due to the unique technology that allows sutureless positioning and anchoring at the implantation site. This approval will give the opportunity to patients in the adult age with aortic stenosis or steno-insufficiency disease to be treated with this curative biological sutureless solution.

Clinical experience with this innovative device is growing rapidly. To date over 5,000 patients worldwide benefit from a Perceval sutureless aortic valve with seven years of clinical experience.

The most recent clinical results were presented at the 50th STS Annual Meeting in Orlando, USA by M Shrestha, Hannover Medical School, Hannover, Germany; M Glauber, G Pasquinucci, Heart Hospital, Massa, Italy; C Muneretto, University of Brescia Medical School, Brescia, Italy; and by F Pollari, Klinikum Nuremberg, Nuremberg, Germany.

“We are consistently achieving key milestones with our breakthrough Perceval platform. With the recent approval of the Perceval XL model and now the adult age indication, we are now bringing Perceval clinical benefits to a larger number of patients,” says Michel Darnaud, president, Cardiac Surgery Business Unit, Sorin Group.