Italy's Sorin nails CE mark for stentless aortic valve replacement

Sorin gained a crucial CE mark for a new biological aortic valve replacement that doesn't leave a stent behind.

The Italian cardiac device company said it won the Europe Union's regulatory signoff for its Freedom Solo Smart aortic valve replacement. It is made without synthetic material and contains a removable stent that is taken out once surgeons suture the valve in place.

Sorin touts the Solo Smart as a big step up from the existing standard of care because it mimics a natural aortic valve, works more effectively over a larger area and leads to a major improvement in quality of life for patients. The stent is meant to support the valve until it is sewn in.

Cutting edge valve technology can only help Sorin as it works to generate new growth. For the 2013 second quarter, Sorin experienced a 12% drop in mechanical heart valve sales and saw declines in its cardiac rhythm management business due to European pricing pressures and competition in Japan.

Those results come in the context of an otherwise successful Q2. Sorin booked nearly $249 million in revenues, 2.7% higher than the 2012 second quarter. Net profit nearly hit $19 million, double the same period a year ago as the company shook off the lingering effects of a 2012 earthquake.

Aortic valve replacement is also becoming fiercely competitive in other areas. Edwards Lifesciences ($EW) and Medtronic ($MDT) continue to battle in a nasty patent fight over transcatheter aortic heart valve replacement tech. Edwards argues that Medtronic's CoreValve system violates patents it has for the Sapien valve, but a German appeals court recently lifted an injunction in that country allowing CoreValve sales to resume.

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