Sorin Group (BIT:SRN) said the FDA granted conditional approval for an investigational device exemption for its SonR cardiac resynchronization device.
The Italian medical device company said it will launch the Respond CRT trial to evaluate the SonR device in more than 1,000 U.S. patients with advanced heart failure.
Sorin, a major player in the European cardiac device market, is trying to make inroads in the U.S. with its line of pacemakers and defibrillators. President Stefano Di Lullo told MassDevice.com in May that the SonR technology is the company’s most promising and innovative technology, calling the device "1 of the major innovations in the marketplace today."
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"The SonR system with its innovative sensor is a significant CRT engineering advancement," said Jagmeet Singh, principal investigator in the Respond trial and director of Mass. General’s Cardiac Resynchronization program in Boston. "Respond CRT is the largest trial to date studying this system, and thus we hope to gain valuable evidence further demonstrating that the SonR system offers a significant clinical advancement and can improve heart failure symptoms for a larger number of patients."
Last December, Sorin announced approval in Japan for a different cardiac device, the Mitroflow heart valve. In September 2012, the company won CE Mark approval for its Perceval bio-prosthetic valve.
