Sorin Group has received CE Mark approval for the XL version of Perceval, a sutureless biological valve indicated for the rapid and minimally invasive surgical replacement of the aortic valve in patients suffering from aortic stenosis.
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.
This approval expands the Perceval portfolio, permitting cardiac surgeons to treat patients with annulus sizes ranging 19mm-27mm.
According to the company, Perceval 'size XL' expands the number of patients that can benefit from a sutureless aortic valve replacement.
Aortic stenosis, one of the most common valvular heart abnormalities, is a degenerative disease resulting from a progressive age-dependent build-up of calcium that disrupts blood flow across the aortic valve.
A recent published retrospective observational study of 137 patients showed reduction in operating time with no intra-operative mortality, shorter intensive care unit (ICU) and hospital stay (a median of one and seven days respectively).
The authors concluded that Perceval sutureless is a safe, effective and feasible bioprosthesis that can easily be implanted through a minimally invasive technique.
Dr Lorenzo Pradelli recently presented the positive health economic results at AdRes and Dr Marco Ranucci at S Donato Hospital (Milan, Italy) during the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) congress (Berlin, 2-6 November).
According to authors, implantation of a sutureless valve seems to be the right choice, is expected to improve clinical outcomes and to lower operating and complication costs.
The significant reduction in operating time for suturing is expected to enhance clinical outcomes and to reduce operating and complication costs.
Sorin Group Cardiac Surgery business unit president Michel Darnaud said the company is consistently achieving key milestones regarding the Perceval platform.
"Patients with XL sizes represent a considerable percentage of the eligible population for aortic valve replacement, therefore, our additional size is a great opportunity to treat patients with the latest therapies," Darnaud said.
According to GlobalData estimates, the tissue aortic valve replacements market in Europe was valued at $301m in 2012 and is expected to grow at a CAGR of 5.5% to reach $436.7m by 2019.
Image: Perceval XL sutureless aortic valve. Photo: courtesy of Sorin Group/ Business Wire.