SORIN GROUP ANNOUNCES PUBLICATION OF FULL CLEAR STUDY RESULTS IN PEER REVIEWED CARDIOLOGY JOURNAL

Sorin Group, (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced today at Heart Rhythm 2012, the Heart Rhythm Society’s 33^rd Annual Scientific Sessions, the publication of the CLEAR study results, in Europace, Advance Access publication, 1 May 2012, doi:10.1093/europace/eus059. The study demonstrates the clinical benefit of the SonR sensor based cardiac resynchronization therapy (CRT) optimization system in heart failure (HF) patients².

SonR is the first and only system to provide weekly automatic optimization during patient’s daily activities as an alternative to in-clinic manual echocardiography-based device settings³. The unique SonR system consists of a dedicated sensor embedded in the tip of a pacing lead implanted with the CRT device. The sensor’s advanced technology allows direct measurement of real-time cardiac contractility and uses this hemodynamic signal to optimize the device’s parameters for each individual patient at rest and exercise.

The CLEAR clinical study, a prospective, multicenter, single-blind, randomized study conducted in 51 centres in 8 European countries enrolled 238 patients with severe HF, i.e., New York Heart Association (NYHA) functional class III and IV and a left ventricular ejection fraction (LVEF) <35%. Study results at 1 year showed that with SonR’s regular automatic optimization of the device’s atrio-ventricular and inter-ventricular delays, 76% of patients were classified as improved, compared with 62% in the group of patients with standard CRT programming (p=0.0285).

"The publication of the CLEAR study is a remarkable milestone in the treatment of heart failure patients indicated for CRT. The regular automatic optimization provided by SonR demonstrates significant increase in the proportion of heart failure patients improving with this therapy. It is the first time a device-based algorithm has demonstrated the ability to improve patient outcomes in a prospective, randomized trial,” commented Philippe Ritter, M.D. University Hospital of Bordeaux, France and principal investigator of the CLEAR clinical trial. "CRT optimization is usually performed in non-responder patients through an expensive, complex and time-consuming echocardiographic procedure. The SonR system optimization is automatic, individualized and performed on a regular basis by the device in all patients. It has the potential to reduce the number of echocardiographic procedures and its related costs,” he added.

"We are very satisfied with the results of the prospective, randomized CLEAR trial which demonstrates that the SonR system provides unique clinical benefit for CRT patients. These results clearly highlight our ongoing commitment to innovation in the hemodynamic management of heart failure patients,” said Stefano Di Lullo, Sorin Group, President of the CRM Business Unit.

About CRT Therapy

Cardiac resynchronization therapy 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 CRT⁴⁵. 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 benefits⁶. All of these current methods require manual steps. They are typically performed only once and only while the patient is resting.

About SonR

The result of a 10-year clinical science program, the SonR sensor uniquely measures patient’s cardiac muscle vibrations related to the first heart sound. 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 contractility, a key indicator of cardiac performance. SonR is the only CRT optimization system that automatically optimizes patients every week and importantly, while the patient is active, providing real-life optimization.

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 3,750 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.

¹ Not for sale or distribution in the US

² Study results obtained through 1st generation SonR

³ Sorin Group, data on file

⁴ Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002 Jun13;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.