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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 -- Advanced Neuromodulation Systems (ANS (ANS Communications, Inc, Purchase, NY) An ISP, Internet backbone and provider of private data network services, founded in 1990 as Advanced Network & Services, Inc., by IBM, MCI and Merit (consortium of Michigan universities). ), the neuromodulation business of St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE

See: New York Stock Exchange
:STJ STJ Superior Tribunal de Justica (Brazil)
STJ Supremo Tribunal de Justiça (Portugal)
STJ Superconducting Tunnel Junction
STJ San Giljan (postal locality, Malta) 
), today announced Australian Therapeutic Goods Administration The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia.  (TGA See TARGA.

TGA - Targa Graphics Adaptor
) 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 The Royal North Shore Hospital (RNSH) is a major public teaching hospital in Sydney, Australia, located in St Leonards. It serves as a teaching hospital for the University of Sydney and has approximately 740 beds.  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 spinal cord, the part of the nervous system occupying the hollow interior (vertebral canal) of the series of vertebrae that form the spinal column, technically known as the vertebral column.  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 The International Association for the Study of Pain (IASP) is an international professional organisation for doctors and other health professionals involved in the diagnosis, treatment and scientific study of pain, as well as education and training in the field of pain medicine.  (IASP IASP International Association for the Study of Pain
IASP International Association of Science Parks
IASP International Association for Suicide Prevention
IASP Information Assurance Scholarship Program
IASP Independent Auxiliary Storage Pool
), 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 Nervous system disorders

A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency
. Based in Plano, Texas, ANS (www.ans-medical.com) 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 Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. , 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Oct 3, 2006
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