Sorin said the approval expands the addressable patient population from just people over age 65 with with aortic stenosis or steno-insufficiency disease to adults with those conditions.
Sorin won CE Mark approval for the XL version of the Perceval valve last year. More than 5,000 patients have been implanted with the device, according to a press release.
Data from a 243-patient study of the Perceval valve, presented at the Society of Thoracic Surgeons annual meeting in January, "confirmed Perceval’s excellent and stable hemodynamic performance, short operation time and very low complication and mortality rates," even in patients who underwent associated procedures including coronary artery bypass grafts, atrial fibrillation treatment or septal myectomy, according to the release.
The valve bested both traditional surgically implanted valves and transcatheter aortic valve implants in terms of "operating time reduction, intra-operative mortality and length of ICU and hospital stay" in 2 other studies, Sorin said.
"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," cardiac surgery president Michel Darnaud said in prepared remarks.