Sorin Group Launches SonR® Sensor Based Cardiac Resynchronization Therapy (CRT) Optimization System (1)

Sorin Group (MIL:SRN) (Reuters Code: SORN.MI), a global medical company and a leader in the treatment of cardiovascular diseases, announced today at the Venice Arrhythmias 2011 Congress, CE Mark approval and the European commercial launch of its innovative SonR CRT optimization system. The SonR system includes the SonR hemodynamic sensor embedded in the SonRtip^TM atrial pacing lead and the Paradym^TM RF SonR CRT-D device. SonR is the first and only system to provide weekly automatic optimization during patient’s real life activities as an alternative to in-clinic manual echocardiography-based device optimization for improved CRT response³.

CRT is a therapy that delivers timely electrical pulses to the chambers of the heart. This allows the heart to beat in a more coordinated and synchronized manner, thus more effectively. Studies have shown that around one-third of patients with advanced heart failure do not effectively respond to cardiac resynchronization therapy (CRT)^4,5. In order to improve therapy success rate, it is important to offer each patient a tailor-made programming of the timing between electrical impulses sent to different parts of the heart (CRT settings) on a regular basis. Current optimization methods include echocardiography and other device-based timing features. Echocardiography is difficult and time-consuming while other device-based CRT optimization features have shown limited benefits². All of these current methods require manual steps. They are typically performed only once and only while the patient is resting. SonR is the only CRT optimization system that automatically optimizes patients every week and importantly, while the patient is active, providing real life optimization. Promising early clinical results suggest that SonR increases responder rates and reduces heart failure hospitalizations compared with standard medical practice over a 1-year follow-up⁶.

The result of a 10-year clinical science program, the SonR sensor uniquely measures patient’s cardiac muscle vibrations. These real-time measurements are transmitted to the CRT-D device which uses them to determine the best settings for the patient. Every week, the system automatically optimizes to adapt to the patient’s changing condition. SonR measurements correspond to LVdP/dt_max, the gold standard for assessing left ventricular (LV) contractility, a key indicator of cardiac performance.

"The concordance of the SonR signal with measurements of LVdP/dt_max suggests that this new, operator-independent system is a reliable means of tailored optimization of CRT devices,” commented Philippe Ritter, M.D. at University Hospital, in Bordeaux, France. "Providing weekly optimization both at rest and exercise is a significant step forward in the treatment of heart failure patients.”
"The SonR system is the result of Sorin Group’s tradition of excellence in innovation,” commented Stefano Di Lullo, Sorin Group, President of the CRM Business Unit, "We are proud to bring this technological breakthrough to market. The introduction of this new CRT-D system provides new horizons in heart failure treatment options and is a reflection of our commitment to innovation in the hemodynamic management of heart failure patients.”

About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The Company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,700 employees worldwide, Sorin Group focuses on three major therapeutic areas: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.

For more information, please visit www.sorin.com

¹ Not for distribution in the US
² Sorin Group, data on file
³ CLEAR results obtained through 1^st generation SonR
⁴ Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002 Jun 13;346(24):1845-53.
⁵ Abraham WT, Gras D, Yu CM et al. Results from the FREEDOM trial – assess the safety and efficacy of frequent optimization of cardiac resynchronization therapy. SP08. Late-Breaking Clinical Trials, HRS 2010. Denver, Colorado.
⁶ Padeletti L. Clinical efficacy of CRT continuous optimization with SonR versus standard clinical practice.HRS 2010;7(5S):AB27_4.