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St. Jude Medical Receives Japanese Approval For Atlas II Implantable Cardioverter Defibrillator

St. Jude Medical, Inc announced regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW), in addition to reimbursement approval, of its Atlas II implantable cardioverter defibrillator (ICD). It is a device used to treat patients with potentially lethal abnormal heart rhythms. The Atlas II ICD is a powerful device which significantly enhances telemetry speed for faster communications, up to five times faster than predecessor devices that results in quicker, more convenient follow-up visits for patients and physicians. The new device provides physicians and patients with therapy enhancing benefits, including: • DeFT Response technology that is designed to help devices meet the needs of patients who may have high or varying thresholds for the amount of energy required to defibrillate the heart. This enables the physician to tailor device therapy for individual patients, offering them added protection in the event of a life-threatening arrhythmia. • SenseAbility technology that is designed to optimize sensing to help protect against inappropriate shocks. • Vibrating patient notifier which gently vibrates to notify patients of critical changes in device performance instead of issuing the standard audio alert; this can be especially beneficial for people with hearing loss. "The Atlas II DR ICD has many features that our physicians really need. DeFT Response technology helps us to ensure appropriate defibrillation safety margins, and the SenseAbility feature provides us with more control to address sensing-related matters. The patient notifier is also very helpful, as it alerts patients by vibrating, which helps those who have difficulty hearing audible alarms," said Takashi Kurita, M.D., associate professor in the department of cardiovascular internal medicine, Kinki University, Osaka, Japan. "The Atlas II devices offer important clinical benefits due to their high-energy capability, advanced diagnostics and increased telemetry speed," said William Phillips, president of St. Jude Medical Japan Co. Ltd. "Customized options give physicians more control and help simplify patient management through better detection, diagnosis and delivery of tailored therapy." An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). An ICD delivers potentially life-saving therapy from the device to the patient's heart through an insulated wire or lead.