Sorin Group (BIT:SRN) said that a patient in Indianapolis was the first U.S. recipient of its recently approved Solo Smart aortic heart valve.
Sorin claims the Solo Smart as the 1st valve on the U.S. market to feature a removable stent.
The FDA approved Solo Smart, which is made from bovine tissue, this past summer after winning CE Mark approval in the European Union in November 2013. The valve is a next-generation version of the Freedom Solo valve, which has been on the market in Europe since 2004.
"The first U.S. implant of Solo Smart is a huge milestone for Sorin," cardiac surgery business president Michel Darnaud said in prepared remarks.
Milan-based Sorin produces cardiopulmonary products for open-heart surgery and heart-valve repair, as well as pacemakers, defibrillators and other devices to treat arrhythmia.
In the 2nd quarter, Sorin earned $12.7 million on $242 million in revenue, with sales of tissue heart valves up 3% from a year earlier to $21.7 million.
Sorin’s main U.S. office is located in Arvada, Colo.