The world’s smallest dual chamber pacemaker from Italian firm The Sorin Group has received EU’s CE Mark of approval, and now has been implanted in the first patient, according to the company. The 8cc device sports the company’s proprietary pacing mode, SafeR™:
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™ reduces pacing in the ventricle to less than 0.1 percent in the same patients. 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™, the REPLY™ pacemakers bring together advanced, automatic features that provide easier patient management by simplifying device checks.
The first REPLY™ 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 Aimé, M.D., 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." 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.