Healthcare Industry News:  cardiac resynchronization therapy 

Devices Cardiology Regulatory

 News Release - October 4, 2006

St. Jude Medical Announces European Approval of Atlas II ICD and Atlas II Heart Failure Devices

Powerful, high-energy devices are designed to help both typical and more challenging patient cases

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval of its newest high-powered devices for treatment of patients with potentially lethal heart arrhythmias and heart failure (HF).

The Atlas(TM) II implantable cardioverter defibrillator (ICD) and the Atlas(TM) II HF cardiac resynchronization therapy defibrillator (CRT-D) devices include advanced features that provide more tailored therapy and speed follow-up visits for physicians and patients.

The Atlas II devices also take advantage of the company's newly released QuickOpt(TM) feature, which helps physicians improve patient outcomes by providing programmer-based optimization in less than two minutes. The QuickOpt feature electrically characterizes the conduction properties of the heart and uses an exclusive algorithm to calculate the optimal timing values, allowing for efficient and frequent optimization during routine device follow-up visits. The QuickOpt feature has proven comparable to a traditional echocardiography (echo) procedure for determining optimal device settings; however, echo optimization can be costly and time-consuming and typically takes between 30 and 120 minutes.

In addition, the Atlas II devices offer significantly enhanced 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.

Another innovative feature is a "patient notifier" that gently vibrates to alert patients, including those who have difficulty hearing, of critical changes in device function so they know to contact their physicians.

"Enhanced technology makes the devices much faster to use, especially when downloading stored electrograms. The vibrating patient notifier will benefit patients who may have difficulty hearing the audio alerts that have been standard to the industry," said Dr. Alexander Bauer, Ruprecht Karls Universitat Heidelberg, Germany (Head: Prof. Dr. Hugo A. Katus), who recently implanted an Atlas II VR ICD.

Dr. Christian Lampersberger, who implanted an Atlas II+ DR ICD at Landesklinikum St. Polten, Austria, also believes the device will save significant time and spare patients from additional procedures. "The DeFT Response(TM) feature is very beneficial in that it provides a way to noninvasively manage those who may experience high defibrillation thresholds," said Dr. Lampersberger. "Also, the QuickOpt optimization feature is exciting new technology, as it will help to provide more tailored therapy for patients and save clinic time."

Professor Luigi Padeletti implanted an Atlas II HF CRT-D at Careggi Hospital, Florence, Italy.

The Atlas II ICD and Atlas II HF CRT-D devices are two of more than 20 new cardiac rhythm management products that St. Jude Medical plans to introduce this year.

"The Atlas II devices offer important clinical benefits due to their high energy capability, advanced diagnostics, increased telemetry speed and innovations such as the vibrating patient notifier feature," said Michael J. Coyle, president of St. Jude Medical's Cardiac Rhythm Management Division. "These devices enhance our portfolio of products designed to meet the needs of clinicians and patients - including the recently launched Merlin(TM) Patient Care System, with its suite of advanced diagnostics."

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 11,000 people worldwide. For more information, please visit 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, regulatory approvals, anticipated future product launches, 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 Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Report on Form 10-Q filed on August 7, 2006 (see page 31 and Item 1A on page 32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

Issuer of this News Release is solely responsible for its content.
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