Healthcare Industry News:  St. Jude Medical 

Devices Cardiology Regulatory

 News Release - June 13, 2006

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

First European Implant of Epic II ICD in Switzerland

ST. PAUL, Minn.--(HSMN NewsFeed)--June 13, 2006--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval of its newest devices for treating patients with potentially lethal heart arrhythmias and heart failure.

The Epic(TM) II ICD (implantable cardioverter defibrillator) and the Epic(TM) II HF CRT-D (cardiac resynchronization therapy defibrillator) feature faster device data transmission to speed patient follow-up exams and a "patient notifier" that gently vibrates to alert patients of critical changes in device function.

Johannes Holzmeister, M.D., and Firat Duru, M.D., professor and director of Pacing and Electrophysiology at the University Hospital of Zurich, Switzerland, performed the first European implant of the Epic II VR ICD.

"Telemetry in the new Epic II ICD is noticeably faster, particularly when downloading stored electrograms," said Prof. Dr. Firat Duru. "The device also includes the industry's first vibration-based patient notifier. Unlike other products on the market that use an audible notifier, the Epic II device may be particularly helpful for patients who have trouble hearing."

The Epic II devices, which received U.S. Food and Drug Administration (FDA) approval in May 2006, include:
  • Faster telemetry, designed to speed data from the ICD to the system programmer at a rate up to five times faster than previous St. Jude Medical devices.
  • The industry's first non-audio alert, which vibrates to notify patients of critical changes in device performance so they can contact their clinician for follow-up care.
  • SenseAbility(TM) technology (ASC), a proprietary St. Jude Medical technology designed to protect against inappropriate ICD shocks.
  • AutoIntrinsic Conduction Search (AICS), intended to promote more natural heart function and minimize ventricular pacing. Studies have shown that excessive ventricular pacing may contribute to heart failure in some patients.
  • DeFT Response(TM) technology designed to help physicians manage patients who require higher levels of defibrillation.
"The Epic II devices offer important benefits to patients and their physicians, including an innovative patient notification feature, advanced diagnostics and the ability to conduct faster follow-up exams," said Eric S. Fain, M.D., executive vice president of Development and Clinical/Regulatory Affairs for St. Jude Medical's Cardiac Rhythm Management Division. "These devices, along with the recently launched Merlin(TM) Patient Care System, provide state-of-the-art technology to European physicians as they manage the complexities of heart failure."

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms, 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.

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 sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition that affects approximately 22 million people worldwide, according to the Heart Rhythm Society.

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 10,000 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 success, 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 the risk factors described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and the cautionary statements described in the Company's Quarterly Report on Form 10-Q filed on May 9, 2006 (see pages 29-30). 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

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