Global medical company Sorin has obtained CE Mark approval for the XL version of Perceval, a bioprosthetic device designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery.
The CE Mark approval for the XL version of Perceval sutureless aortic valve is for treating patients with annulus sizes ranging from 19–27mm.
According to Sorin, the Perceval implant is easy, safe and reproducible due to its unique technology that allows sutureless positioning and anchoring at the implantation site.
According to a recently published retrospective observational study of 137 patients, the Perceval implant demonstrated savings in operating time for suturing, no intra-operative mortality, shorter intensive care unit and hospital stay.
The authors concluded that the implant used in minimally invasive aortic valve replacement is a feasible, effective and safe device.
Positive health economic results were recently presented during the International Society for Pharmacoeconomics and Outcomes Research congress in Dublin, Ireland, (2 November through 6 November 2013).
Sorin 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 added.
According to the company, Perceval ‘size XL’ expands the number of patients that can benefit from a sutureless aortic valve replacement.