Healthcare Industry News:  CarboMedics 

Devices Regulatory Cardiology

 News Release - March 1, 2007

The Sorin Group Announces CE Mark and First Implants of Advanced, Next-Generation Pacemakers in Europe

New REPLY(TM) Pacing Systems Promote the Patient's Natural Heart Rhythm Through SafeR (TM) Pacing Mode

MILAN, Italy--(HSMN NewsFeed)--The Sorin Group (MIL:SRN) announced today CE Mark approval and first implants of its next-generation REPLY(TM) pacemakers, the world's smallest dual-chamber devices (8cc). This new pacemaker line is designed to deliver automatic, physiologic pacing adapted to patients who have bradyarrhythmia (slow ventricular rhythms).

The REPLY(TM) pacemakers integrate the Sorin Group's proprietary and exclusive SafeR(TM) pacing mode that constantly monitors the patient's natural cardiac activity and reduces the amount of pacing delivered to the right ventricle, thereby promoting natural cardiac function.

Delivering unnecessary pacing to the right ventricle has been shown to significantly enhance the risk of patients developing heart failure and atrial fibrillation, two conditions that can prove fatal and place a heavy cost burden on healthcare systems.

While conventional pacemakers deliver unnecessary ventricular pacing in patients without heart block 50 to 80 percent of the time, SafeR(TM) reduces pacing in the ventricle to less than 0.1 percent in the same patients(1). Heart block is an electrical conduction disorder that results in the inability of the atria and ventricles, the heart's chambers, to beat in a synchronized way.

In addition to SafeR(TM), the REPLY(TM) pacemakers bring together advanced, automatic features that provide easier patient management by simplifying device checks.

The first REPLY(TM) pacemaker implants were successfully performed by Dr. Georg Noelker, M.D., in the Internal Medicine Department headed by Professor Johannes Brachman, M.D., Klinikum Coburg, Germany and by Dr. Ezio Aime, M.D., at the IRCCS Policlinico of S. Donato, Milan.

Professor Brachman commented: "I've been using the first generation of SafeR(TM) since its introduction in 2003. This exclusive pacing technology has brought tremendous benefits to my patients who are now given chances to rely on their heart's natural conduction when it is intact. I really appreciate SafeR(TM) because it provides optimal pacing therapy to my patients."

The SafeR(TM) technology builds on the Sorin Group's proven AAIsafeR(TM) mode, the first pacing mode designed to limit unnecessary ventricular pacing that was available in a pacemaker. AAIsafeR(TM) was first launched in September 2003 in Europe and received FDA approval in May 2005. Sorin Group was the first company to receive U.S. market clearance for a pacemaker incorporating a pacing mode that minimizes ventricular pacing.

"My experience is that the Sorin Group's technology really has an edge in terms of the clinical benefits it brings to my pacemaker patients. After implanting the REPLY(TM) pacemakers, I am amazed that such a small device contains such a broad arrray of advanced features," said Dr. Ezio Aime.

Other implants were also performed by Dr. Guy Pioger, M.D., Alleray Clinic, Paris and Dr. Christine Alonso, M.D., at the Bizet Clinic, Paris.

Andre-Michel Ballester, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit commented: "As a European leading company in bradycardia management, we are proud to have developed a new pacemaker family that builds on our legacy of innovation in cardiac rhythm management. Featuring cutting-edge chip and algorithm technology, the REPLY(TM) pacemaker line is yet another example of the Sorin Group's commitment to develop devices that provide flexibility in tailoring pacing therapy to individual patients".

The Sorin Group expects to introduce its new pacemaker platform on the European market within the next few months. U.S. market release is planned to follow.

(1) Davy JM et al. Determining the optimal pacing mode to prevent ventricular pacing: SAVE R study results. Heart Rhythm 2006; 3, supp 5, S169, P2-94 (abs)

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: Dideco, CarboMedics, Inc., COBE Cardiovascular, Inc., Stockert, Mitroflow, ELA Medical, Inc., Sorin Biomedica, Bellco and Soludia. It has more than 4,500 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.

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Source: Sorin Group

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