Sorin Group gained the FDA's backing to begin a U.S. clinical trial for its new sutureless aortic tissue valve. This is a major win for the Italian cardiac device giant as it pushes to diversify its offerings, overcome earthquake damage and counter declining pacemaker and defibrillator sales.
Regulators' conditional approval covers the launch of an investigational device exemption clinical trial at up to 25 U.S. centers for Sorin's Perceval S device. Researchers will pursue a non-randomized test of the implant to gauge its safety and effectiveness, and that data will help support a premarket approval (PMA) application. Perceval S has had CE marking in Europe since 2011, the company notes. Surgeons implant the device either through open-heart surgery or a minimally invasive cardiac surgery partial sternotomy or right mini-thoracotomy implantation procedure.
Approval for the trial follows a recent conditional FDA nod to start U.S. testing of SonR, the company's cardiac resynchronization therapy system for advanced heart failure. And it also comes the same day Sorin announces financials still showing the effects of a 2012 earthquake.
Sorin reported $234.1 million in revenues for its 2013 first quarter, down 5% from the same period last year, due to the continued aftermath of a May 2012 earthquake. Adjusted net profit reached the $11.9 million mark. The company's cardiac surgery unit generated $150.4 million in revenues, with a jump in demand for heart-lung machines and tissue heart valves, but a decline in mechanical heart valve revenue. Cardiac rhythm management revenues dropped to $82.6 million, a decline of nearly 8% reflecting lower global demand for pacemakers and defibrillators, plus pricing pressure in Europe and reimbursement changes in Japan.
- read the study release
- here's Sorin's Q1 2013 announcement