Healthcare Industry News:  AAIsafeR 

Devices Cardiology

 News Release - April 20, 2006

Sorin Group Stresses Key Role of Innovative Pacing Technology in Avoiding Unnecessary Ventricular Pacing at Mannheim Cardiology Congress

Sorin Group Begins European Awareness Campaign on the Risks Associated with Unnecessary Pacing of the Right Ventricle

MANNHEIM, Germany--(HSMN NewsFeed)--April 20, 2006--The Sorin Group (MIL:SRN) Cardiac Rhythm Management (CRM) Business Unit, a leader in the development of cardiac rhythm management therapies, will focus on its innovative pacing mode, AAIsafeR(TM), and on the utmost importance of preventing over-pacing of the heart's right ventricle at the 72th annual meeting of the German Society of Cardiology in Mannheim from April 20th to April 22rd. Sorin Group will be discussing its latest technology during a symposium on the opening day. This symposium concurs with a European awareness campaign launched by Sorin Group to alert physicians on the risks associated with unnecessary ventricular pacing.

Several clinical studies have demonstrated that unnecessary right ventricular pacing from cardiac implantable devices significantly increases the risk of patients developing heart failure (HF) and atrial fibrillation (AF). HF and AF are two cardiac diseases that can prove fatal to patients while placing a heavy cost burden on healthcare systems.

In response to this growing evidence, Sorin Group has developed a unique pacing mode, AAIsafeR, which is designed to avoid unnecessary ventricular pacing by promoting the patient's natural electrical conduction (AV conduction). By regularly monitoring AV conduction, AAIsafeR pacing can automatically switch from physiological atrial-based (AAI) stimulation to right ventricular pacing (DDD) when necessary, i.e. only when normal AV conduction does not occur or occurs too slowly, causing blocks in the heart's natural electrical pathway (AV blocks).

AV blocks are classified into three categories according to the level of AV conduction impairment, first degree being the most benign and third degree the most severe form.

AAIsafeR is the only mode currently available that manages all types of heart blocks by delivering right ventricular pacing (DDD) only when needed. AAIsafeR also responds to conduction disorders occurring at night and to those occurring while exercising, thus allowing maximum comfort and safety for patients.

AAIsafeR pacing mode reduces unnecessary ventricular pacing to 0.1%(1), an unprecedented performance which significantly reduces risks of HF hospitalization, AF and mortality for patients while treating all heart blocks. It is estimated that 60% of pacemaker patients with dual-chamber indications could benefit from AAIsafeR.

"Because it favors intrinsic atrioventricular conduction in all situations, AAIsafeR pacing mode has the potential to become a gold-standard therapy for the vast majority of dual-chamber pacemaker and ICD patients," concluded Dr. Christof Kolb from the German Heart Center in Munich (Germany), a speaker at the Mannheim Congress.

Sorin Group is currently conducting a series of workshops with cardiologists and electrophysiologists throughout Germany as part of a European awareness campaign to alert them on the importance of avoiding unnecessary right ventricular pacing.

Michael Zwick, Sorin Group's CRM Business Director in Germany, confirmed that "it is important for Sorin Group to fully inform physicians on the positive effects of avoiding right ventricular over-pacing. AAIsafeR exemplifies Sorin Group CRM commitment to provide physicians with solutions that ensure maximum safety and comfort for patients. Positive feedback to our workshops throughout Germany indicates that physicians are receptive to the campaign and understand its importance".

Sorin Group:

Sorin Group CRM Business Unit designs and manufactures implantable pacemakers and ICDs, leads and Holter equipment and markets them worldwide.

Sorin Group (Reuters code: 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. Sorin Group includes: Dideco, CarboMedics, COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. Sorin Group has more than 4,700 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.

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(1) In pacemaker patients with intrinsic conduction. Results of SaveR study, premarket clinical study, September 2004: cumulative percent pacing stored in the pacemaker data. In ICD patients with intrinsic conduction AAIsafeR reduces ventricular pacing to 0.2%. Internal clinical release report.

Source: Sorin Group

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