CLEAR study meets primary endpoint: Sorin Group

Sorin Group (MIL:SRN) (Reuters Code: SORIN.MI), a global leader in the treatment of cardiovascular diseases, announced today that the CLEAR study has met its primary endpoint.

“This is a giant step forward in improving heart failure patient care and a reflection of our commitment to innovation in the hemodynamic management of heart failure patients.”

The CLEAR study, with 156 patients enrolled in 51 centers in 8 countries, is sponsored exclusively by Sorin Group. The study demonstrates reduced mortality and heart failure (HF) related hospitalization in patients whose cardiac resynchronization therapy was optimized on a regular basis.

Sorin Group's SonR technology consists of a sensor embedded in the tip of a pacing lead implanted with a CRT device. The sensor measures real-time cardiac contractility and the CRT device utilizes this hemodynamic data to regularly optimize the therapy delivered.

Final results show that regular optimization of CRT patients using Sorin Group's SonR sensor technology improves clinical response rate to 86% as compared to 62%, in patients receiving standard medical treatment.>

Patients in sinus rhythm and with severe heart failure, New York Heart Association (NYHA) Class III and IV, were enrolled in the CLEAR study. The CLEAR study Steering Committee expects to present and publish the trial's full results later this year.

The CLEAR study was a prospective, multicenter, randomized, single-blind study conducted over the course of 1 year under the leadership of Principle Investigator, Dr. Philippe Ritter, University of Bordeaux, France.

"The results of the CLEAR study are very encouraging as they demonstrate regular automatic optimization significantly increases the responder rate of HF patients by improving hemodynamic performance" said Dr. Philippe Ritter. "The SonR system is capable of automatically optimizing CRT pacing intervals regularly and has the potential of reducing time-consuming ECHO procedures associated with CRT optimization," he added.

"The CLEAR study results demonstrate that regular optimization of CRT with our innovative SonR technology improves patient outcomes," said Stefano Di Lullo, President of the Sorin Group CRM business unit. "This is a giant step forward in improving heart failure patient care and a reflection of our commitment to innovation in the hemodynamic management of heart failure patients."

SOURCE Sorin Group