Sorin Group introduces advanced defibrillation therapy to Japanese
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.
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
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
“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.
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
3. Samuel F. Sears, Jr, PhD; Julie B. Shea, MS, RNCS; Jamie B. Conti, MD.
How to Respond to an Implantable Cardioverter-Defibrillator Shock.
4. Hintringer F. et al. Comparison of the Specificity of Implantable Dual
Chamber Defibrillator Detection Algorithms. PACE 2004, vol.27: