Healthcare Industry News:  Spinal Cord Stimulator 

Devices Regulatory

 News Release - October 3, 2006

Advanced Neuromodulation Systems Receives Australian Regulatory and Reimbursement Approval for Rechargeable Chronic Pain System

Sydney patients among first to be implanted with new pain device

PLANO, Texas & SYDNEY, Australia--(HSMN NewsFeed)--Advanced Neuromodulation Systems (ANS), the neuromodulation business of St. Jude Medical, Inc. (NYSE:STJ ), today announced Australian Therapeutic Goods Administration (TGA) regulatory approval for its Eon(TM) Rechargeable Neurostimulation System. In Australia, the Eon system is fully reimbursable via the private health system.

Patients at the Pain Management Research Institute, Royal North Shore Hospital in Sydney, were among the first to receive the Eon system. Pain Medicine Specialist Professor Michael Cousins, M.D., who performed one of the first surgeries, said, "Eon was easy to implant and the patients continue to gain substantial pain relief. With its rechargeable battery, Eon is a good option for patients who require high-power stimulation settings and need to use the system for a large percentage of the day."

Eon delivers spinal cord stimulation (SCS) therapy to treat chronic, intractable pain of the trunk and limbs, including pain associated with failed back surgery syndrome. Similar to a cardiac pacemaker, this "pacemaker for pain" uses mild electrical pulses from leads selectively placed near the spinal cord to interrupt pain signals to the brain.

Eon contains the highest-capacity rechargeable battery available, which is designed to last a minimum of seven years at high-power settings. This allows patients to go longer between battery replacement surgeries. The rechargeable technology is easy for patients to understand and use - they simply recharge the device periodically, similar to recharging a mobile phone. Eon can power up to 16 independent electrodes, which allows clinicians more programming options to better manage the patient's pain.

"Approval of the Eon system provides physicians in Australia with a new tool to combat chronic pain," said Chris Chavez, president of ANS. "The full power of the Eon system is realized when coupled with advanced clinician programming features of Rapid Programmer 3.0, such as Dynamic MultiStim and Active Balancing. Eon and this programming platform work together as an integrated system to provide clinicians greater speed, precision and effectiveness in addressing complex pain."

Chronic pain is a largely under-treated and misunderstood disease that affects millions of people worldwide. The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that "One in five people suffers from moderate to severe chronic pain, and one in three is unable or less able to maintain an independent lifestyle due to pain." Spinal Cord Stimulators like Eon often allow patients to greatly reduce their need for potent and potentially addictive pain medication.

Eon was approved by the U.S. Food and Drug Administration in 2005. Approximately 25,000 patients in more than 25 countries around the world use ANS neurostimulation devices to manage chronic pain.

About ANS, the Neuromodulation Business of St. Jude Medical

Advanced Neuromodulation Systems (ANS) is an innovative technology leader dedicated to the design, development, manufacturing and marketing of implantable neuromodulation systems to improve the quality of life for people suffering from disabling chronic pain and other nervous system disorders. Based in Plano, Texas, ANS ( is a division of 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 11,000 people worldwide. For more information, please visit

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: Advanced Neuromodulation Systems

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