Business, cardiology  

Sorin Group introduces advanced defibrillation therapy to Japanese market

23 October 2006

Tokyo, Japan. Sorin Group (MIL:SRN) (ISIN:IT0003544431) has announced the market launch and first implants of the ALTO 2 line of implantable cardioverter defibrillators (ICDs) manufactured by its subsidiary ELA Medical. These are the first ICDs from ELA Medical to be released in Japan.

ALTO 2 ICDs are intended for patients at risk from sudden cardiac arrest (SCA). They are capable of accurately detecting and appropriately treating fast rhythm disorders through mild stimulation (anti-tachycardia pacing) or higher energy shocks.

The single chamber and dual chamber models ALTO 2 VR and DR ICDs received regulatory and reimbursement approval from the Ministry of Health, Labor and Welfare (MHLW). Both ICD models are immediately available.

The first implants of ALTO 2 were successfully performed by Dr. Akihiro Yoshida MD, Cardiovascular Internal Medicine, Kobe University Hospital, and by Dr. Katsumi Matsumoto, MD, and Dr. Kohei Matsushita, MD, in the Department of Cardiovascular Internal Medicine headed by Dr. Toshiyuki Ishikawa, Associate Professor, Yokohama City University Hospital, (Japan).

Dr. Ishikawa declared: “In addition to being the best-in-class arrhythmia discrimination algorithm, PARAD+ is the only arrhythmia management feature that integrates a true dual chamber architecture offering me a comprehensive monitoring of the two chambers of the heart. This exclusive specificity will enable me to better manage all my ICD patients”.

It is estimated that 80,000 people die from sudden cardiac arrest every year in Japan. Sudden cardiac arrest is a condition caused by life-threatening arrhythmias such as ventricular tachycardia (VT) and ventricular fibrillation (VF).

Inappropriate therapies remain a major issue for ICD patients. Studies have shown that up to 35% of patients(1) and up to 50% of young patients still receive unnecessary shocks(2). For patients with ICDs, the possibility of receiving a shock can cause anxiety or depression, which can negatively impact their quality of life. In fact, up to 38% of ICD patients experience significant anxiety(3).

Featuring the highly-regarded PARAD + arrhythmia detection function, ALTO 2 DR has a 99%(4) specificity (only one out of 100 shocks delivered may be unnecessary), thus offering unrivalled discrimination of ventricular tachyarrhythmias and reduction in the number of inappropriate shock therapies.

PARAD+ also allows a unique management of slow ventricular tachycardias (VTs). Slow VTs are ventricular tachyarrhythmias of less than 150 beats per minute that can have serious consequences on patients with impaired heart pumping function. With ALTO 2, these slow VTs are appropriately treated through mild stimulation (anti-tachycardia pacing).

“We are pleased to bring the ALTO 2 ICD line to Japanese patients and provide them with state-of-the-art therapeutic solutions against sudden cardiac arrest. The approval of this life-saving device is the result of a fruitful collaboration with MHLW, the Japanese regulatory body. Since its creation in 1988, ELA Medical Japan, a Sorin Group company, has marketed small, advanced cardiac pacemakers that are widely acknowledged as offering optimal pacing therapy to patients. Today’s introduction of ALTO 2 ICDS expands Sorin Group’s cardiac rhythm management product offering and is a testament of Sorin Group’s determination to better serve the needs of Japanese cardiologists and electrophysiologists and their patients”, said Nam Lee, Sorin Group Vice-President, Japan & Asia-Pacific and Sorin Group Japan President.

References

1. Long-term outcome of patients who receive implantable cardioverter defibrillators for stable ventricular tachycardia. Glikson M. et al. Jour. Cardiov. Electrophys June 2004

2. High incidence of appropriate and inappropriate ICD therapies in children and adolescents with implantable defibrillator. Korte T et al. PACE July 2004

3. Samuel F. Sears, Jr, PhD; Julie B. Shea, MS, RNCS; Jamie B. Conti, MD. How to Respond to an Implantable Cardioverter-Defibrillator Shock. Circulation 2005;111:e380-e382.

4. Hintringer F. et al. Comparison of the Specificity of Implantable Dual Chamber Defibrillator Detection Algorithms. PACE 2004, vol.27: 976-982

To top

To top