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Devices Cardiology FDA

 News Release - May 15, 2008

Sorin Group Announces FDA Approval of the World's Smallest Cardiac Resynchronization Implantable Cardioverter Defibrillator: OVATIO(TM) CRT

DENVER, Colo.--(HSMN NewsFeed)--The Sorin Group (MIL:SRN), the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, announces the U.S. Food and Drug Administration’s (FDA) approval to market the CRT model of its OVATIO™ family. Coupled together with the Situs™ OTW left ventricle pacing lead, this device will now allow US physicians to treat their heart failure patients with a complete Sorin Group system.

OVATIO™ CRT 6750, the smallest CRT defibrillator (CRT-D) available worldwide (30cc, 11mm) is shaped to offer ease of implantation and long-term patient comfort, and is designed to allow more flexibility in the management of cardiac resynchronization and anti-tachyarrhythmia therapy, thanks to a unique feature: Brady-Tachy Overlap (BTO).

Maintaining CRT during exercise, including at elevated heart rates, might allow the patient to experience prolonged, and eventually, beneficial physical activity1. However heart failure patients present a high incidence of “slow” ventricular tachycardias (VT) which heart rates coincide with exercise rates2. These arrhythmias have been reported to cause significant clinical effects3. Managing these conflicting aspects is challenging and usually either CRT delivery has to be favoured at the expense of slow VTs protection, or inversely. OVATIO™ CRT’s BTO feature is designed to “Unlock Pacing and Detection”, to ensure delivery of resynchronization therapy during exercise without any compromise on the management of slow VTs.

“I like the fact that with the smallest CRT-D in the world I can resynchronize my patients during maximal exercise as well as detect and treat slower ventricular tachycardias without programming constraints”, stated Dr Michael R. Gold, Medical University of South Carolina, Charleston, South Carolina (USA).

Moreover, OVATIO™ CRT performs best-in-class detection of arrhythmia thanks to P And R Arrhythmia Detection (PARAD®/PARAD®+). Studies demonstrated that PARAD+ has a superior specificity in discriminating atrial from ventricular arrhythmias: the absolute risk of experiencing an inappropriate shock has been observed to be only 5%, the lowest percentage reported thus far4. For heart failure patients it is crucial that life saving therapies are delivered when necessary, and only when necessary, to improve quality of life.

"The OVATIO™ CRT-D system completes the range of Sorin Group defibrillators available in the US, in addition to OVATIO™ single- and dual-chamber defibrillators and to the ISOLINE™ defibrillation lead. It is a big step towards strengthening our position in the US by entering the $ 2 billion CRT segment and offering a complete solution to patients and physicians”, said Fred Hrkac, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit.

The OVATIO™ CRT will be distributed in the United States by ELA Medical, Inc., a Sorin Group Company.

About heart failure and resynchronization

With 550,000 new cases diagnosed annually in the United States, heart failure is the most costly cardiovascular disease. Approximately $40 billion are dedicated annually to the treatment of this debilitating condition, which affects 5 million5 Americans. Cardiac Resynchronization Therapy Defibrillators are indicated in heart failure patients who might be at risk for Sudden Cardiac Death (SCD). CRT-D devices are capable of restoring a better coordination of the heartbeats, which has been proven to improve quality of life, increase exercise capacity, and reduce hospitalizations and mortality in these patients. CRT-D devices also provide patients with anti-tachyarrhythmia therapies when abnormally fast, life-threatening rhythms occur.

About the Sorin Group

The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. The Sorin Group includes these brands: Dideco, CarboMedics, COBE Cardiovascular, Stöckert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Bellco-Soludia. At the Sorin Group 4,500 employees work to serve over 5,000 public and private treatment centers in more than 80 countries throughout the world.

For more information, please visit: www.sorin.com or www.sorin-crm.com.

1 Auricchio, A., et al. Exercise Performance Following Cardiac Resynchronization Therapy In Patients With Heart Failure and Ventricular Conduction Delay. The American Journal of Cardiology, Vol. 89 January 15, 2002

2 Data on file extracted from N Sadoul, R Mletzko, F Anselme, for the Slow VT Study Group Incidence and Clinical Relevance of Slow Ventricular Tachycardia in Implantable Cardioverter-Defibrillator Recipients: Circulation 2005; 112: 946-53

3 Bansch D et al. Ventricular tachycardias above the initially programmed tachycardia detection interval in patients with implantable cardioverter-defibrillators: incidence, prediction and significance. J Am Coll Cardiol. 2000 Aug;36(2):557-65.

4 AnselmeF et al: Prevention of Inappropriate shocks in ICD Recipients: A review of 10000 Tachycardia Episodes. PACE, Vol 30, January 2007, Supplement 1

5 Circulation – Journal of the American Association – ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult – Summary Article – p. 1826


Source: Sorin Group

Issuer of this News Release is solely responsible for its content.
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