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
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.
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
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).