CE mark for XL version of Perceval surgical aortic valve

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Sorin has announced that it has received the CE mark for the XL version of its Perceval bioprosthetic aortic valve, which is designed to replace a diseased native or malfunctioning prosthetic aortic valve using either traditional or minimally invasive heart surgery. This approval expands the Perceval portfolio, permitting cardiac surgeons to treat patients with annulus sizes ranging from 19mm to 27mm

According to a press release, a recent published retrospective observational study of the Perceval valve in 137 patients shows operating time reduction, no intra-operative mortality, shorter Intensive Care Unit (ICU) and hospital stay (a median of one and seven days respectively). The authors conclude that Perceval used in minimally invasive aortic valve replacement is a feasible, effective and safe 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,” said Michel Darnaud, president, Cardiac Surgery Business Unit, Sorin Group.