Sorin Group has announced it has received CE mark approval for extended indications of Perceval S, as well as for an entirely re-designed 2nd generation set of implantation accessories. Perceval 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.
The implantation of this valve 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 2nd generation implantation accessories for PercevalS were designed to provide enhanced ease of use and ergonomics, as well as specific implantation accessories for the minimally invasive cardiac surgery implantation of the valve either through a partial sternotomy or right mini-thoracotomy.
“After its initial European market clearance in 2011, PercevalS, a unique sutureless aortic valve, has proven to be a revolution in cardiac surgery, optimising both operating time and clinical outcomes,” said Davide Bianchi, president, Heart Valves Business Unit, Sorin Group.