|Sorin has kicked off an FDA-targeted trial for its self-regulating CRT system.--Courtesy of Sorin|
Italy's Sorin has notched its first implantation in a large-scale trial designed to win FDA approval for SonR, a cardiac resynchronization implant the company touts as more responsive than anything on the market.
Sorin is looking to enroll more than 1,000 patients in the U.S. and abroad to test SonR's safety and effectiveness in heart-failure sufferers. The device is outfitted with a hemodynamic sensor, reading patients' heart function and automatically tweaking its shocks, a system Sorin said could help treat patients who have never responded to cardiac resynchronization therapy.
"We've seen excellent clinical results from other studies of SonR," Cardiac Rhythm Management President Stefano Di Lullo said in a statement. "Our goal is to obtain FDA approval in the United States where more than 5 million Americans suffer from heart failure."
In an earlier trial of 238 European patients, 76% of patients treated with Sorin's device reported improved heart function, compared to 62% of those implanted with standard CRT implants.
SonR is a big part in Sorin's ambitious CRM expectations this year. In 2012, an earthquake in the biomedical hub of Mirandola cost the company millions in sales, but with new product launches and expanded indications Sorin believes it can increase annual net profit by up to 30% and crank up CRM revenue between 3% to 5% in 2013.
- read the announcement
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