Sorin Group Completes Enrollment in the RESPOND CRT IDE 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 that it has reached the target enrollment for RESPOND CRT, an Investigational Device Exemption (IDE) clinical trial. The trial studies the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with severe heart failure.

The SonR system features a unique hemodynamic sensor which assesses the patient’s left ventricular contractility to automatically optimize the atrioventricular (AV) and interventricular (VV) settings – with the goal of improving the patient’s response to CRT.

RESPOND CRT has enrolled a total of 1,039 patients in Europe, USA and Australia. The patients have been randomized to receive either SonR weekly automatic optimization or manual echocardiography optimization at pre-discharge visit and are followed in a double-blinded fashion. The primary effectiveness endpoint will be evaluated at the 12-month follow-up. Results are expected in spring 2016.

“I am very impressed by the interest of the investigators in the RESPOND CRT trial,” said Prof. Josep Brugada, Hospital Clinic, University of Barcelona, Spain, principal study investigator. “Thanks to their support we have been able to achieve the enrollments ahead of schedule. I am pleased with the continued progress of this very large study aiming to further demonstrate that heart failure patients can benefit from SonR automatic optimization. I look forward to the one-year follow-up results”.

The RESPOND CRT study is designed to build upon Sorin’s CLEAR clinical study which evaluated the SonR CRT optimization system in 238 European patients. The published CLEAR results^1,2 showed that at 12 months 76 percent of patients receiving SonR CRT optimization were classified as improved, compared with 62 percent in the control patient group followed with standard practice (p=0.0285).

“RESPOND CRT is a key trial to further demonstrate the clinical benefits of our innovative SonR technology”, said Stefano Di Lullo, President CRM Business Unit, Sorin Group. “After SonR’s successful introduction in Europe, this study serves as a cornerstone to obtain FDA approval and to make this unique solution available to many of the five million³ Americans suffering from heart failure”.

About the SonR RESPOND CRT Trial
RESPOND CRT is a pivotal multi-center, randomized, two-arm, double-blinded, prospective trial. 1,039 patients have been enrolled in this study in Europe, USA and Australia. The composite primary endpoint of death, HF re-hospitalization, NYHA class and quality of life will be evaluated at the 12-month follow-up. Mid to long-term effectiveness will be assessed at 18 and 24 months.

About SonR
The SonR hemodynamic sensor is designed to uniquely measure a patient’s cardiac muscle vibrations which reflect the left ventricular contractility, a key indicator of cardiac performance. These real-time measurements are transmitted to the CRT implantable device which determines the best settings for the patient. The system automatically optimizes to adapt to the patient’s changing condition, 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 CRT⁴. In order to improve the therapy’s 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 benefits⁵. 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 over 3,500 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 100 countries.

For more information, please visit www.sorin.com

¹ 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.

² CLEAR results obtained through 1st generation SonR

³ Roger LV. The Heart Failure Epidemic. Int J Environ Res Public Heath. 2010 April; 7(4):1807-1830.

⁴ Abraham WT, Fisher WG, Smith AL et al. Cardiac resynchronization in chronic heart failure. N Engl J Med 2002; 346(24):1845-53

⁵ Cuoco FA, Gold M. Optimization of Cardiac Resynchronization therapy: Importance of Programmed Parameters. J Cardiovascular Electrophysiology 2012; 23(1):110-8.

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Contact information

Gabriele Mazzoletti, Tel: +39 02 69969785
Mobile: +39 348 979 22 01
Director, Corporate Communications
Sorin Group
e-mail: corporate.communications@sorin.com
or
Francesca Rambaudi, Tel: +39 02 69969716
Director, Investor Relations
Sorin Group
e-mail: investor.relations@sorin.com