Sorin Group (BIT:SRN) said it won CE Mark approval in the European Union for the XL version of its Perceval sutureless aortic valve.
Milan-based Sorin said the new approval is for treating patients with annulus sizes ranging from 19 mm to 27 mm using the Perceval device.
“We are 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,” cardiac surgery president Michel Darnaud said in prepared remarks.
Sorin won CE Mark approval for its stentless aortic valve late last week. The Solo Smart heart valve is the next iteration of its Freedom Solo replacement valve and features a removable stent to provide support while the valve is sewn in place and then removed.