Bangalore, July 17, 2007: St Jude Medical has received regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, for the company's first CRT-D systems in Japan to treat heart failure patients.

 

Two new systems used to treat heart failure patients have been approved, including the Atlas+ HF CRT-D (cardiac resynchronization therapy defibrillator) and the Epic HF CRT-D that are used in conjunction with the QuickSite left-heart lead and delivered through the Apeel CS catheter delivery system.

 

“St. Jude Medical is pleased to offer products that will help physicians in Japan meet the varying needs of their heart failure patients by providing CRT-D systems with high energy, small size and flexible therapy options,” said Mr Joe McCullough, President of St Jude Medical's International Division.

 

With these approvals, physicians in Japan now have two sophisticated devices that treat the complexities of heart failure by combining pacemaker therapy, ICD (implantable cardioverter defibrillator) therapy and cardiac resynchronization therapy.

 

The Atlas+ HF CRT-D is capable of delivering high output and tailored waveforms, giving added security to patients whose hearts may be especially difficult to defibrillate.

 

The Epic HF CRT-D – one of the smallest CRT-Ds available – is designed for improved patient comfort, particularly for patients for whom small size is critical.

 

Cardiac resynchronization therapy - delivered in an ICD or a pacemaker - resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of synchrony in heart failure patients. Studies, such as the RHYTHM ICD study, have shown that CRT can improve cardiac performance and quality of life for many patients with heart failure.

 

The Atlas+ HF and Epic HF CRT-D devices monitor every heartbeat and provide resynchronization therapy to reduce the symptoms of moderate to severe heart failure. They also can adjust therapy to promote biventricular pacing (pacing both of the heart's lower chambers, or ventricles, to resynchronize the rhythm). In addition, the device's technology helps physicians manage patients' defibrillation thresholds (the level of energy required to stop a life-threatening arrhythmia). The devices are also designed to allow physicians to fine-tune sensing capabilities to deliver therapy only when needed.