Sorin will begin clinical testing on its SonR cardiac assist device after the FDA grants a conditional investigational device exemption.
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.”