CE Mark for Extra Large Sizes of Sorin’s Perceval™ Sutureless Aortic Valve

Last week we covered the news that Italian cardiovascular outfit Sorin had gained CE mark approval for its Solo Smart stentless heart valve. Now the company tells us it has also gained the European nod for the large sizes of its sutureless Perceval valve.

Background

The Perceval platform represents something of a gap filler, providing a sutureless heart valve that can be used in minimally invasive (but not transcatheter) aortic valve implantation. Featuring biological and metallic stent components the device can be implanted using either traditional or minimally invasive heart surgery. Sorin claims implantation of its device is easy, safe and reproducible due to the unique technology that allows sutureless positioning and anchoring at the implantation site.

This new approval expands the Perceval portfolio, permitting cardiac surgeons to treat patients with annulus sizes ranging from 19 mm to 27 mm.

Company comments

“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,” said Michel Darnaud, President, Cardiac Surgery Business Unit, Sorin Group.

Source: Sorin Group, SpA, Business Wire

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