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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 Milan, prince and king of Serbia
Milan (Milan Obrenović) (mĭl`än ōbrĕ`nəvĭch), 1854–1901, prince (1868–82) and king (1882–89) of Serbia; grandnephew of Miloš Obrenović.
, Italy -- The Sorin Group (MIL:SRN SRN (formerly in Britain) State Registered Nurse ) 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 ventricle /ven·tri·cle/ (ven´tri-k'l) a small cavity or chamber, as in the brain or heart.ventric´ular

ventricle of Arantius  the rhomboid fossa, especially its lower end.
 to less than 0.1 percent in the same patients1. Heart block is an electrical conduction disorder that results in the inability of the atria Atria
The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps.
 and ventricles Ventricles
The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues.
, 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 IRCCS Istituto Di Ricovero e Cura a Carattere Scientifico (Italian Research Hospital)  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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 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 Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs.  (CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization. ) Business Unit commented: "As a European leading company in bradycardia bradycardia: see arrhythmia.  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 COBE: see infrared astronomy.  Cardiovascular, Inc., Stockert, Mitroflow, ELA Noun 1. ELA - an extreme leftist terrorist group formed in Greece in 1971 to oppose the military junta that ruled Greece from 1967 to 1974; a revolutionary group opposed to capitalism and imperialism and the United States
Revolutionary People's Struggle
 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.

For more information, please visit our web site: www.sorin.com or www.sorin-crm.com.
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Publication:Business Wire
Date:Mar 1, 2007
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