Cardiology, business  

First implants and EU approval for Sorin REPLY pacemakers

8 March 2007

Milan, Italy. The Sorin Group (MIL:SRN) has received CE Mark approval and experienced the first implants of its next-generation REPLY pacemakers. This new pacemaker line, which Sorin claims has the world’s smallest dual-chamber device (8cc), is designed to deliver automatic, physiologic pacing adapted to patients who have bradyarrhythmia (slow ventricular rhythms).

The REPLY pacemakers integrate the Sorin Group’s proprietary and exclusive SafeR 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% of the time, SafeR reduces pacing in the ventricle to less than 0.1% 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.

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

Professor Brachman commented: “I’ve been using the first generation of SafeR 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™ because it provides optimal pacing therapy to my patients.”

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.

André-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.”

The Sorin Group expects to introduce its new pacemaker platform on the European market within the next few months. US 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).

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