Sorin Group Receives Conditional FDA Approval to Conduct RESPOND CRT Clinical Trial Using Innovative Heart Failure Management Technology

Sorin Group (MIL:SRN), (Reuters Code: SORN.MI), a global medical device company and a leader in the treatment of cardiovascular diseases, announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies.

The SonR optimization system is comprised of the SonR hemodynamic sensor embedded in the SonRtip^TM atrial pacing lead and the PARADYM^TM RF SonR CRT-D device, which includes a unique algorithm to automatically optimize the patient’s atrioventricular (AV) delay and interventricular (VV) delay timing. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT^1,2. The SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis. The timing of electrical impulses delivered to the heart is based on the patient’s heart activity and need – with the goal of improving the patient’s response to CRT. Typically this device re-programming is done manually in the clinic using echocardiography.

"The SonR system with its innovative sensor is a significant CRT engineering advancement,” said Jagmeet P. Singh, M.D., Ph.D., Director of the Cardiac Resynchronization Program at Massachusetts General Hospital in Boston and U.S. principal investigator of the RESPOND CRT trial. "RESPOND CRT is the largest trial to date studying this system, and thus we hope to gain valuable evidence further demonstrating that the SonR system offers a significant clinical advancement and can improve heart failure symptoms for a larger number of patients.”

The RESPOND study is designed to build upon Sorin’s earlier clinical experience with its first-generation SonR device, as shown by the CLEAR clinical study described in the September 2012 issue of the peer-reviewed journal Europace. The published results from the CLEAR clinical study^3,4 which evaluated the use of the first generation SonR CRT optimization system in 238 European patients with advanced heart failure, showed that at 12 months 76 percent of patients receiving SonR CRT optimization were classified as improved, compared with 62 percent in the group of patients with standard CRT programming (p=0.0285).

"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,” said Stefano Di Lullo, Sorin Group, President of the CRM Business Unit. "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 failure⁵.”

About the SonR RESPOND CRT Trial
RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial. It is anticipated that the trial will start enrolling U.S. patients in the first half of this year. The trial will enroll more than 1,000 patients in over 100 worldwide investigational sites, with approximately one-third of patients in the United States.

The primary effectiveness endpoint is the proportion of patients within each treatment group that responded to CRT therapy with an improvement in NYHA class or an improvement in quality of life at 12 months and did not experience a heart failure-related adverse event or death. Patients will be followed for 24 months.

About SonR
The result of a 10-year clinical science program, the SonR sensor is designed to uniquely measure 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. The SonR CRT optimization system received CE Mark in October 2011 and is currently one of the most widely used CRT systems in Europe. SonR is the only CRT hemodynamic sensor-based optimization system that is designed to automatically optimize patients every week and, importantly, while the patient is active, providing real-life optimization.

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, and thereby more effectively. Studies have shown that around one-third of patients with advanced heart failure do not effectively respond to CRT. 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. Most of these current methods require manual steps. They are typically performed only once and while the patient is resting.

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, the Company focuses on two major therapeutic areas: Cardiac Surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and Cardiac Rhythm Management (pacemakers, defibrillators and non invasive monitoring to diagnose and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment). 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 Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002;346(24):1845-53
² Young JB, Abraham WT, Smith AL, et al. Combined cardiac resynchronization and implantable defibrillation in advanced chronic heart failure: the MIRACLE ICD trial. JAMA 2003; 289(20):2685-94.
³ Ritter P, Delnoy PP, Padeletti L et al. A Randomized pilot study of optimization of cardiac resynchronization therapy in sinus rhythm using a peak endocardial acceleration sensor vs. standard methods. Europace 2012 Sep; 14(9):1324-33.
⁴ CLEAR results obtained through 1st generation SonR
⁵ Roger LV. The Heart Failure Epidemic. Int J Environ Res Public Heath. 2010 April; 7(4):1807-1830.
⁶ Cuoco FA, Gold M. Optimization of Cardiac Resynchronization therapy: Importance of Programmed Parameters. J Cardiovascular Electrophysiology 2012; 23(1):110-8.