MILAN, March 15 /PRNewswire-FirstCall/ -- - SYMPHONY(r) AAIsafeR(tm) 2 promotes the patient's natural cardiac activity by pacing the right ventricle only when AV blocks occur.
Drago Cerchiari, CEO of Sorin Group, announces that ELA Medical, a Sorin Group cardiac rhythm management company, today released the SYMPHONY(r) AAIsafeR(tm) 2 pacing system, its second-generation pacemaker that minimizes ventricular pacing(1), on the European market.
The AAIsafeR(tm) 2 pacing mode is intended to promote the patient's intrinsic electrical conduction by drastically limiting the amount of unnecessary, often deleterious pacing delivered to the right ventricle. This is also the primary objective of Medtronic's Managed Ventricular Mode(tm) (MVP(tm)).
AAIsafeR(tm) 2 manages to reduce ventricular stimulation to 0.1% in patients with intermittent atrio-ventricular conduction(2). This represents as little as 1 min 30 sec ventricular pacing per day or 9 hours per year!
With AAIsafeR(tm) 2, unnecessary ventricular pacing is 40 times less than with other systems available on the market.
SYMPHONY(r) AAIsafeR(tm) 2 builds on the clinically-proven SYMPHONY(r) pacing systems with AAIsafeR(tm) mode that was launched in Europe in September 2003.
The launch is effective immediately and will be accompanied by a special Privilege Program aimed at medical institutions that implant the first generation of SYMPHONY(r) pacing systems.
The time-limited Privilege Program will run from the beginning of March to the end of April 2005. Throughout this two-month period, healthcare facilities that implanted SYMPHONY(r) pacemakers with AAIsafeR will have the one-time opportunity to upgrade all SYMPH0NY(r) to SYMPHONY(r) AAIsafeR(tm) 2 pacing systems. Therefore, physicians will be able to offer SYMPHONY(r) patients the new AAIsafeR(tm) 2 mode with broader indications and keep their pacemaker at the cutting edge of technology.
SYMPHONY(r) AAIsafeR(tm) 2 suppresses deleterious ventricular pacing
Several clinical studies have shown that over-pacing the right ventricle may increase the risk of developing heart failure and atrial fibrillation. These two conditions are known to be major cost-drivers for healthcare systems worldwide as they cause high hospitalization rates.
The SYMPHONY(r) AAIsafeR(tm) 2 pacing system is designed to minimize deleterious ventricular pacing by promoting the patient's natural electrical conduction and delivering safe, physiological atrial-based pacing (AAI pacing) as primary therapy.
Permanent checks of the patient's natural conduction allows the SYMPHONY(r) AAIsafeR(tm) 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, SYMPHONY(r) AAIsafeR(tm) 2 automatically switches back to physiological AAI pacing.
SYMPHONY(r) AAIsafeR(tm) 2: Unique management of the individual pacemaker patient
Unlike other devices that attempt to minimize ventricular pacing, SYMPHONY(r) AAIsafeR(tm) 2 not only addresses patients with bradycardia caused by sinus node dysfunction, or brady-tachy syndrome. It is also indicated for patients with any type of transient atrio-ventricular blocks, permanent first degree blocks, and paroxysmal atrial fibrillation. In addition, SYMPHONY(r) AAIsafeR(tm) 2 is the only pacing system capable of managing atrio-ventricular conduction disorders that may occur at exercise or at night.
Altogether, SYMPHONY(r) AAIsafeR(tm) 2 efficiently withholds deleterious ventricular pacing in 60 percent of dual-chamber paced patients(3).
Minimized ventricular pacing not only offers enhanced patient comfort, it also extends the device longevity by two years.
SYMPHONY(r) AAIsafeR(tm) 2: A one-of-its-kind AV conduction diagnosis
In addition to reducing deleterious ventricular pacing, SYMPHONY(r) AAIsafeR(tm) 2 includes advanced diagnostic features which offer the physicians a comprehensive insight into the patient's intrinsic AV conduction. Unique stored intracardiac EGMs provide information on the onset of AV blocks.
The device is the first pacing system capable of delivering safe and physiological single chamber therapy while collecting and analyzing dual chamber diagnostic information. The patient thus benefits from the best of both options.
"We believe this unique technology can fully match the patients' need for more physiological pacing. We are pleased to offer electrophysiologists and cardiologists a therapy that delivers 40 times less unnecessary ventricular pacing than what is achieved with other systems available on the market", said Drago Cerchiari.
"SYMPHONY(r) AAIsafeR(tm) 2 is intended to provide enhanced safety and comfort to the patient and cutting-edge technology to the physicians to help them in the management of patients with different needs. With this second generation of the AAIsafeR mode, ELA becomes a leader in the treatment of all types of AV conduction disorders", said AndrÃ?Â©-Michel Ballester, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit.
In addition to suppressing unnecessary ventricular pacing, SYMPHONY(r) AAIsafeR(tm) 2 is a full-featured dual-chamber pacemaker which includes:
- atrial fibrillation prevention features;
- advanced diagnostic functions (7-minute EGMs);
- and fast follow-up tools.
SYMPHONY(r) AAIsafeR(tm) 2 is the first product in ELA's new generation of CRM products to include the AAIsafeR(tm) 2 mode. ELA's next Implantable Cardiac Defibrillator (ICD), which will be launched in late 2005, will also feature this advanced pacing mode.
ELA Medical, a Sorin Group Company, designs and manufactures implantable pacemakers and ICDs, leads, Holter equipment and electrophysiology catheters and markets them in Europe, the U.S. and Japan.
The Sorin Group (Reuters code: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm management, interventional cardiology and the treatment of chronic kidney diseases. The companies of the Sorin Group are: Dideco, CarboMedics, COBE Cardiovascular, StÃ?Â¶ckert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. The Sorin Group has about 4,800 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.
For more information please visit: http://www.sorin.com/
(1) This feature is currently not available in the U.S.
(2)Results of SaveR study, premarket clinical study, September 2004: cumulative percent pacing stored in the pacemaker data.
(3) Herzschr Elektrophys 2002 ; 13 : 242-257. Danish, German and Swiss registry.