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Press release
SORIN
GROUP
LAUNCHES
SONR®
SENSOR
BASED
RESYNCHRONIZATION THERAPY (CRT) OPTIMIZATION SYSTEM1
CARDIAC
SonR is the only weekly self-adjusting CRT optimization system providing
optimized timing at rest and exercise for improved CRT response2
th
Venice, Italy, October 12 2011 –Sorin Group (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
TM
system. The SonR system includes the SonR hemodynamic sensor embedded in the SonRtip atrial pacing
TM
lead and the Paradym 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
3
echocardiography-based device optimization for improved CRT response .
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
4,5
resynchronization therapy (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
2
CRT optimization features have shown limited benefits . 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
6
follow-up .
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/dtmax, the gold standard for
assessing left ventricular (LV) contractility, a key indicator of cardiac performance.
1
Not for distribution in the US
Sorin Group, data on file
CLEAR results obtained through 1st 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):184553.
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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.
2
3
“The concordance of the SonR signal with measurements of LVdP/dtmax suggests that this new, operatorindependent 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, or contact:
Martine Konorski
Director, Corporate Communications
Sorin Group
Tel: +33 (0)1 46 01 33 78
Mobile: +33 (0)6 76 12 67 73
e-mail: [email protected]
Francesca Rambaudi
Director, Investor Relations
Sorin Group
Tel: +39 02 69969716
e-mail: [email protected]