The Sorin Group announces european market release of Reply™, the world’s smallest pacemaker
99.9% spontaneous atrioventricular conduction ensured in 80 percent of dual-chamber pacemaker patients.
Paris, France / Denver, Colorado, USA – May 9, 2007 – The Sorin Group announced today the European market release of its advanced, next-generation REPLY™ pacemakers, the world's smallest dual-chamber pacemakers (8cc).
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.
SafeR™ reduces pacing in the ventricle to 0.1 percent in patients without heart block1. Furthermore, recently published results have shown that patients with different degrees of heart block may also benefit from this pacing mode2.
The SafeR™ technology builds on the Sorin Group's proven AAIsafeR™ mode, the first pacing mode designed to limit unnecessary ventricular pacing that was available in a pacemaker. AAIsafeR™ 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).
In addition to SafeR™, the REPLY™ pacemakers bring together advanced, automatic features that offer easier patient management by streamlining device checks. Because all programming data needed for followup can be obtained from one touch on the programmer's screen, up to 25% of followup time can be saved.
Dr. Ezio Aimé, IRCCS Policlinico of S. Donato, Milan, Italy commented: "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™ pacemakers, I am amazed that such a small device contains such a broad arrray of advanced features".
Andre Michel Ballester, President Cardiac Rhythm Management (CRM) Sorin Group commented: "The smart features that are today incorporated in our implantable devices allow us to look at the future with confidence. Since more than 40 years we've opened up new ways and pioneered significant technological firsts in the management of cardiac arrhythmias and heart failure with a view to bringing clinical benefits to patients and their physicians. As a European leading company in bradycardia management, we are proud to have developed a new pacemaker family that builds on our legacy of innovations."
Regulatory clearance in the U.S. and Japan is planned early 2008.
(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)
(2) Pioger G, Leny G., Nitzsche R; Ripart A. AAIsafeR Limits Ventricular Pacing in Unselected Patients. PACE 2007; 30: S66-S70)
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., Stöckert, 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.
Jason Mitchell Jacobs
Director, Communication & Media Relations, Sorin Group
Director, Investor Relations, Sorin Group