Healthcare Industry News:  St. Jude Medical 

Devices Cardiology FDA

 News Release - May 16, 2006

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

ST. PAUL, Minn.--(HSMN NewsFeed)--May 16, 2006--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of its newest devices for treating patients with potentially lethal heart arrhythmias and heart failure.

The EpicŪ II ICD (implantable cardioverter defibrillator) and the EpicŪ II HF CRT-D (cardiac resynchronization therapy defibrillator) devices feature significantly enhanced telemetry speed for faster device communications and a "patient notifier" that gently vibrates to alert patients of critical changes in device function.

"I was impressed with the speed of the new Epic II ICD device. Many things were noticeably faster, like the ability to download stored electrograms," said Senthil Natarajan, M.D., Rochester General Hospital, Rochester, N.Y. "The vibrating patient notifier, which is the industry's first non-audio alert, is especially helpful for those patients who have difficulty hearing and would typically rely on a family member to listen for an alert."

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), a condition that kills more than 450,000 people annually in the United States, according to the Centers for Disease Control and Prevention (CDC). 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 in which the heart weakens and loses its ability to pump an adequate supply of blood. About 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed each year, according to the American Heart Association.

The Epic II devices 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 proprietary patient notifier, the industry's first vibrating notifier that issues a vibration instead of an audio alert to notify patients of critical changes in device performance.
  • SenseAbility(TM) technology (ASC), a proprietary St. Jude Medical technology designed to allow optimizing of sensing parameters that may protect against inappropriate ICD shocks.
  • AutoIntrinsic Conduction Search (AICS), intended to promote more natural heart function and minimize ventricular pacing, which is an important clinical consideration since studies such as St. Jude Medical's DAVID (Dual-Chamber And VVI Implantable Defibrillator) trial have shown that excessive ventricular pacing may contribute to heart failure in some patients.
  • DeFT Response(TM) technology to help physicians manage patients who require higher levels of defibrillation.
"The Epic II devices can help physicians meet the needs of even the most challenging patients," 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 a suite of advanced diagnostics, an innovative patient notification feature and the ability to conduct faster follow-up exams."

The Epic II ICD and Epic II HF CRT-D, which will be released for sale this month in the U.S. market, are two of more than 20 new cardiac rhythm management products being introduced this year by St. Jude Medical.

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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