Sorin Group has received CE mark approval for its Perceval sutureless aortic valve, designed for extended age indication.
Previously, the CE mark for Perceval only applied to patients ages 65 and older. 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.
Perceval is a surgical aortic valve with a unique anchoring frame that enables the surgeon to replace the diseased valve without suturing it into place.
Implant with Perceval is easy, safe and reproducible due to the unique technology that allows sutureless positioning and anchoring at the implantation site.
According to the company, clinical experience with this innovative device is growing rapidly and Perceval has been successfully used in more than 5,000 patients around the world so far.
In addition to being the only sutureless valve reimbursed in Belgium, Perceval obtained incentive reimbursement for isolated aortic valve replacement over traditional biological valves from the German healthcare system earlier this year.
Sorin Group cardiac surgery business unit president Michel Darnaud said the company is consistently achieving key milestones with its 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," Darnaud added.
Image: Perceval XL sutureless aortic valve. Photo: courtesy of Sorin Group/ Business Wire.