A Medical Device Daily
Cardiac rhythm management company ELA Medical (Le Plessis Robinson, France) last week reported the Euro-pean release of Symphony AAIsafeR 2, its second-generation pacemaker that minimizes ventricular pacing.
The company said the AAIsafeR 2 pacing mode is in-tended to promote the patient's intrinsic electrical conduction by "drastically limiting" the amount of "unnecessary, often deleterious pacing delivered to the right ventricle."
It said that permanent checks of the patient's natural conduction allows the Symphony AAIsafeR 2 pacing system to deliver right ventricular pacing when normal conduction of the cardiac impulse to the ventricle does not occur. When intrinsic conduction resumes, ELA's new device automatically switches back to physiological AAI pacing.
The company said the AAIsafeR 2 builds on its clinically proven Symphony pacing systems with AAIsafeR mode that was launched in Europe in September 2003, according to ELA Medical.
The launch is effective immediately, ELA said, and will be accompanied by a special Privilege Program running until the end of April, aimed at medical institutions that im-planted the first generation of Symphony systems, during which those facilities will have the opportunity to upgrade all Symphony to Symphony AAIsafeR 2 pacing systems.
The company said that several clinical studies have shown that over-pacing the right ventricle may increase the risk of developing heart failure and atrial fibrillation, conditions known to be major cost-drivers for healthcare systems worldwide.
ELA Medical said AAIsafeR 2 manages to reduce ventricular stimulation to 0.1% in patients with intermittent atrio-ventricular conduction. That represents as little as one minute, 30 seconds of ventricular pacing per day, or nine hours per year, the company said.
With the new device, unnecessary ventricular pacing is 40 times less than with other systems available on the market, said ELA, a Sorin Group (Milan, Italy) company.
ELA said that, unlike other devices that attempt to minimize ventricular pacing, Symphony AAIsafeR 2 "not only addresses patients with bradycardia caused by sinus node dysfunction, or brady-tachy syndrome . . . [but] also is indicated for patients with any type of transient atrio-ventricular blocks, permanent first-degree blocks and paroxysmal atrial fibrillation."
In addition, it said that Symphony AAIsafeR 2 is "the only pacing system capable of managing atrio-ventricular conduction disorders that may occur at exercise or at night."
Altogether, ELA said the new product "efficiently withholds deleterious ventricular pacing in 60% of dual-chamber paced patients."
Minimized ventricular pacing not only offers enhanced patient comfort, it also extends the device longevity by two years, the company said.
"With this second generation of the AAIsafeR mode, ELA becomes a leader in the treatment of all types of AV conduction disorders," said Andr -Michel Ballester, president of the Sorin Group cardiac rhythm management (CRM) business unit.
Symphony AAIsafeR 2 is the first product in ELA's new generation of CRM products to include the AAIsafeR 2 mode. The company said its next implantable cardioverter defibrillator, which will be launched late this year, also will feature the advanced pacing mode.
CE mark sought for HeartMate II
In other cardiovascular sector news, Thoratec (Pleasanton, California) said it has filed for CE mark approval of its HeartMate II LVAS (left ventricular assist system). Approval would allow the commercial launch of the device in Europe.
The HeartMate II is a next-generation heart-assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure. Thoratec received approval last month to begin a Phase II pivotal trial for the device in the U.S., and last week reported that the first patients have been enrolled in both the destination therapy (DT) and bridge-to-transplantation (BTT) arms of that trial.
The regulatory application for European approval is based on data from the first 20 patients that were implanted in Thoratec's Phase I U.S. trial and in a European study. These patients accounted for nearly 5,200 days of cumulative support and were each supported from three to 490 days.
The company said it hopes to receive the CE mark for the device this year.
"Our application seeks approval to use the HeartMate II for long-term support," said D. Keith Grossman, president and CEO of Thoratec. "As we have indicated in the past, the experience to date with the device has been very positive. The level of adverse event trends recorded for this series of patients is significantly lower than what we've seen with our other, currently approved cardiac assist devices."
The HeartMate II is an implantable LVAS powered by a rotary pumping mechanism, weighs about 12 ounces and is roughly the size of a D-cell battery. It is designed to have a much longer functional life than other approved devices and to operate more simply and quietly, Thoratec said.
Once authority to CE mark the device is granted, Thoratec would have four devices approved for sale in Europe.