E.U. Approves Extended Indications for Sorin Group’s Cardiac Device

Milan, Italy-based medical device company Sorin Group has received CE Mark approval for extended indications of Perceval S as well as a redesigned second-generation set of implantation accessories. Perceval S is a bioprosthetic valve designed to replace one that is diseased or a malfunctioning prosthetic aortic valve. The replacement is completed during open heart surgery in a process that allows sutureless positioning and anchoring at the implantation site.

The implantation of Perceval S was previously limited to patients 75 years of age or older. With extended indications, the use of Perceval S now is approved for use in patients 65 years of age or older with aortic valve stenosis or steno-insufficiency. Aortic stenosis, one of the most common valvular heart abnormalities, is a degenerative disease resulting from a progressive age-dependent build-up of calcium that disrupts blood flow across the aortic valve.

According to Sorin, the second-generation accessories for Perceval S are designed to provide enhanced ease of use and ergonomics, as well as specific implantation accessories for the minimally invasive cardiac surgery (MICS) implantation of Perceval S either through a partial sternotomy or right mini-thoracotomy. MICS techniques increasingly are important for aortic valve replacement (AVR) because they reduce surgical trauma and morbidity—an important consideration for the growing number of AVR patients.

“After its initial European market clearance in 2011, Perceval S, a unique sutureless aortic valve, has proven to be a revolution in cardiac surgery, optimizing both operating time and clinical outcomes,” said Davide Bianchi, president of Sorin’s heart valves business unit. “We are excited to provide this innovative treatment to a wider patient population, and to support the cardiac surgeon community to perform more and more minimally invasive cardiac surgeries.”

Sorin Group develops, manufactures and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. Its U.S. offices are located in Arvada, Colo.