Cardiovascular Company Sorin Group has announced CE Mark approval for extended indications of its Perceval™ S bioprosthetic valve, as well as for an entirely re-designed 2nd generation set of implantation accessories.
Perceval S is 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.
The implantation of Perceval S was previously limited to patients 75 years of age or older. With extended indications, the use of Perceval S is now approved for use in patients 65 years of age or older with aortic valve stenosis or steno-insufficiency.
The second piece of news is that Sorin’s new implantation accessories for Perceval S have also been CE marked and according to the company provide enhanced ease of use and ergonomics. Furthermore they now facilitate Minimally Invasive Cardiac Surgery (MICS) implantation of Perceval S either through a partial sternotomy or right mini-thoracotomy.
“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, 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.”
Source: Sorin Group