Italian Cardiovascular device specialist Sorin Group tells us its Perceval™ 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.
Perceval is a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery. Sorin says Perceval implantation is easy, safe and reproducible due to the unique technology that allows sutureless positioning and anchoring at the implantation site.
Until now, only patients over 65 years of age could benefit from the Perceval technology. 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 its innovative device is growing rapidly with over 5,000 patients worldwide already having received the valve over the past seven years.
“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,” said Michel Darnaud, President, Cardiac Surgery Business Unit, Sorin Group.
Source: Sorin Group