Boston Scientific Gets Regulatory Approval And Market Launch In Japan For Its Vitality™ DR Implantable Cardioverter Defribrillator System

Boston Scientific Corporation (NYSE: BSX) today announced regulatory approval and market launch in Japan for its VITALITY™ DR implantable cardioverter defibrillator (ICD) system, the smallest dual chamber ICD currently offered in Japan. ICDs are devices that shock the heart out of abnormal and potentially fatal rhythms.

The VITALITY DR system is based upon the established VITALITY line of products and offers advantages for both patients and physicians. The size and shape of the VITALITY DR, (30cc and 11mm), for example, is designed to facilitate ease of insertion and contribute to patient comfort.

“The regulatory approval of VITALTY DR in Japan represents Boston Scientific’s ongoing worldwide commitment to providing therapies for treating patients who are at known risk for sudden cardiac death,” said Peter Coenen, Vice President, Japan, Boston Scientific Corporation.

The VITALITY DR system incorporates AV Search Hysteresis (AVSH) programming -- a proprietary feature that proactively reduces right ventricular (RV) pacing when the heart’s natural rhythm is present.

“The INTRINSIC RV trial recently showed that dual chamber ICD programming can provide benefits to patients such as improved heart function and enhanced arrhythmia detection,” added Coenen.

INTRINSIC RV trial results were published in the January issue of the journal Circulation.

More than 100,000 ICDs from the VITALITY family have been implanted worldwide since the system was first introduced in Europe in 2002.

Sudden cardiac death is the abrupt loss of heart function, usually due to a potentially fatal electrical rhythm dysfunction in the heart called ventricular fibrillation. Each year, sudden cardiac death claims the lives of as many as 50,000 people in Japan.