MILAN--()--Sorin Group, (Reuters Code: SORN.MI)(MIL:SNR), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today it has received CE Mark approval for extended indications of PERCEVALTM S, as well as for an entirely re-designed 2nd generation set of implantation accessories. PERCEVALTM S is a bioprosthetic valve designed to replace a diseased native or malfunctioning prosthetic aortic valve via open heart surgery with the unique characteristic of allowing sutureless positioning and anchoring at the implantation site.
“After its initial European market clearance in 2011, PERCEVALTM S, a unique sutureless aortic valve, has proven to be a revolution in cardiac surgery, optimizing both operating time and clinical outcomes”
The implantation of PERCEVALTM S was previously limited to patients 75 years of age or older. With extended indications, the use of PERCEVALTM S is now 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.
The 2nd generation implantation accessories for PERCEVALTM S were designed to provide enhanced ease of use and ergonomics, as well as specific implantation accessories for the Minimally Invasive Cardiac Surgery (MICS) implantation of PERCEVALTM S either through a partial sternotomy or right mini-thoracotomy. MICS techniques are increasingly important for Aortic Valve Replacement (AVR) because they reduce surgical trauma and morbidity which is an important consideration for the growing number of AVR patients.
“After its initial European market clearance in 2011, PERCEVALTM 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, Sorin Group, President, 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.”
About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, Sorin Group focuses on three major therapeutic areas: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.
For more information, please visit www.sorin.com