Healthcare Industry News:  Carbomedics 

Devices Cardiology

 News Release - October 22, 2007

Sorin Group Announces the First U.S. Clinical Implant of the World's Smallest Cardiac Resynchronization Implantable Cardioverter Defibrillator - OVATIO(TM) CRT

DENVER, Colo.--(HSMN NewsFeed)--ELA Medical, Inc, a Sorin Group company (MIL:SRN), announced today the first U.S. implant in the Investigational Trial of the OVATIO™ CRT, Cardiac Resynchronization Therapy Defibrillator, Model 6750.

The first clinical implant of OVATIO™ CRT-D, the smallest biventricular ICD currently available outside the U.S. at 30cc, was successfully performed by Dr. Eli S. Gang, Clinical Professor of Medicine, David Geffen School of Medicine, UCLA. The implant occurred at Brotman Medical Center, Culver City, California.

Cardiac resynchronization ICD therapy for heart failure patients at risk of sudden cardiac death (SCD) has become a standard-of-care treatment. Cardiac Resynchronization Therapy (CRT) has been shown, using earlier devices, to improve quality of life, increase exercise capacity, and reduce hospitalizations and mortality.

In patients with poor ventricular function, there is a high incidence of slow ventricular tachycardias (VT) and these arrhythmias have significant clinical effects. A recent publication indicated that not maintaining CRT during exercise might not allow the patient to experience prolonged, and eventually beneficial, physical activity. OVATIOTM CRT’s unique BTO™ feature (Brady-Tachy Overlap) is designed to “Unlock Pacing and Detection” to ensure delivery of resynchronization therapy during exercise.

“I like the fact that with the smallest CRT-D in the world I can pace my patients during exercise as well as detect and treat slower rate VTs without programming constraints”, stated Dr. Eli Gang.

OVATIOTM CRT also includes P And R Arrhythmia Detection (PARAD®/PARAD®+) for maximum specificity of ventricular tachycardia. Studies using earlier ELA ICDs, demonstrated that PARAD+ has a superior specificity in discriminating atrial from ventricular arrhythmias, without a reduction in sensitivity. For heart failure patients, not only is it vital that life saving therapies be delivered when necessary, but also that unnecessary and painful shocks be avoided to improve quality of life.

"The OVATIO™ CRT-D reflects the Sorin Group’s commitment and dedication to the development of innovative, state-of-the-art cardiac rhythm devices that improve patients’ longevity and quality of life”, said Richard Ames, Senior Vice President, U.S. Cardiac Rhythm Management (CRM).

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


Source: Sorin Group

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