St. Jude Medical Announces Japanese Approval Of Atlas II ICD

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 16 Jan 2009 - 0:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) today 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), a device used to treat patients with potentially lethal abnormal heart rhythms.

The Atlas II ICD is a powerful device that significantly enhances telemetry speed for faster communications - up to five times faster than predecessor devices - which 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 - which 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 - which is designed to optimize sensing to help protect against inappropriate shocks.

Vibrating patient notifier - the industry's only notifier that 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 today. 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.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 13,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit http://www.sjm.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical

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