Sorin eyes FDA approval with heart device trial

Sorin is plotting an FDA-targeted trial for its self-regulating CRT system.--Courtesy of Sorin

Sorin has won conditional FDA approval to kick off a U.S. trial of SonR, a cardiac resynchronization therapy system for advanced heart failure.

The Italian devicemaker plans to study its CRT tech in more than 1,000 patients, amassing data on its super-responsive implant with the goal of eventual U.S. approval. Unlike similar devices, SonR can adjust the timing of its shocks on a weekly basis, personalizing heart failure treatment based on a patient's activity levels.

In an earlier trial of 238 European patients, 76% of patients treated with Sorin's device were classified as improved, compared to 62% of those implanted with standard CRT implants. The new trial, dubbed RESPOND CRT, has endpoints of improved heart health and quality of life over 24 months, and Sorin believes the device is up to the task.

"Sorin Group has a long legacy of technology innovations, and the SonR system is an excellent example of our commitment to develop unique solutions to improve therapy effectiveness," CRM President Stefano Di Lullo said in a statement. "Clinical results from international studies of SonR have been very positive, and we hope to extend this base of robust evidence with the RESPOND CRT trial and launch this innovative CRT system in the United States to benefit many of the 5 million Americans with heart failure."

Sorin is bullish about its CRM prospects this year. In 2012, a devastating 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%.

- read Sorin's announcement

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