|Sorin's Perceval sutureless aortic valve--Courtesy of Sorin|
Sorin knows that it needs to reach the widest patient population possible to succeed in the cardiac marketplace. With that in mind, the Italian cardiac medical device company can celebrate its new CE mark allowing its Perceval sutureless aortic valve to be used for all adults with aortic stenosis and related problems.
Surgeons can implant the device now in the general adult population to replace either a diseased aortic valve or a malfunctioning prosthetic one. Previously, the CE mark for Perceval only applied to patients ages 65 and older.
The CE mark also builds on another victory last November, when Sorin nailed down a CE mark for an XL version of Perceval sutureless aortic valve. These products must also be made in multiple sizes to reach a broad swath of patients. Wider age and size options will help spark new business and more revenue, Sorin is betting.
Aortic valve replacements are becoming more commonplace. Medtronic ($MDT) and Edwards Lifesiences ($EW) have fought bitterly overseas and in the U.S. over development and patent ownership of their respective transcatheter aortic heart valve replacements. French researchers have made strides recently with totally endoscopic aortic valve replacement.
In Sorin's case, Perceval is designed to be implanted either through traditional or minimally invasive heart surgery, with the core technology allowing for sutureless positioning and anchoring at the implantation site. The company said Perceval has been successfully used in more than 5,000 patients around the world so far.
Device companies are looking to better aortic valve replacements as a growth area, and Sorin sees the Perceval sutureless valve replacements as helping to drive those revenue hikes. The company expects its cardiac surgery business to grow 4% to 6% annually, driven, in part, by expanded Perceval use. Sorin is also seeking to drive growth in cardiac rhythm management sales through the launch of new pacing products in the space.
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