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Advanced Neuromodulation Systems Receives European CE Mark Clearance for Eon Rechargeable Neurostimulation System; First Patient Implant Completed in Europe.


PLANO, Texas -- 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 it has received European CE Mark clearance for its Eon(TM) Rechargeable Neurostimulation System, and announced the first European patient implant of the Eon System.

The Eon Neurostimulation System helps patients manage chronic, intractable pain of the trunk and limbs, including pain associated with failed back surgery syndrome, by using low-intensity electrical impulses to selectively trigger nerve fibers along the spinal cord. Researchers theorize the·o·rize  
v. the·o·rized, the·o·riz·ing, the·o·riz·es

v.intr.
To formulate theories or a theory; speculate.

v.tr.
To propose a theory about.
 that stimulating these nerve fibers diminishes or blocks the intensity of the pain message being transmitted to the brain, replacing feelings of pain with tingling tin·gle  
v. tin·gled, tin·gling, tin·gles

v.intr.
1. To have a prickling, stinging sensation, as from cold, a sharp slap, or excitement: tingled all over with joy.
 sensations.

Neurosurgeon neurosurgeon

a physician who specializes in neurosurgery.

neurosurgeon A surgeon specialized in managing diseases of the brain, spine and peripheral nerves Meat & potatoes diseases Brain tumors, spinal cord disease Salary $245K + 15% bonus.
 Athanasios Koulousakis, M.D., performed the first European implant at University Hospital in Cologne, Germany. "The Eon was easy to implant and the patient has responded well to the targeted pain relief this neurostimulation therapy offers," said Dr. Koulousakis. "Eon is a good option for patients who need high power stimulation settings and want the convenience of a rechargeable device."

Featuring the highest-capacity rechargeable battery on the market, the Eon implantable pulse generator implantable pulse generator Cardiac pacing A pacemaker used for permanent pacing, which is placed inside a pocket under the skin; the leads are positioned in or on the heart  (IPG IPG Implantable pulse generator, see there ) is designed to last a minimum of seven years at high power settings. This allows patients to go longer between battery replacement surgeries. Eon can power up to 16 independent electrodes, which allows clinicians more programming options to better manage the patient's pain.

"Physicians throughout the European Union will now have a broader choice among neurostimulation systems to treat their patients," said Chris Chavez, president of ANS. "We believe that patients will appreciate how easy the system is to use. They simply recharge the device periodically, just as they would their cell phone."

Spinal cord stimulators like Eon are implanted devices that are similar in function and appearance to cardiac pacemakers. To have a spinal cord stimulator or "pain pacemaker" implanted, a patient must undergo a minor surgical procedure in which a lead or leads are placed in the epidural space and connected to a generator, which serves as the power source and programming "brain." Once activated, the system's programs are adjusted and fine tuned to best control the patient's pain. Patients use a controller (similar to a remote control) that allows them to check the system's battery, adjust the power level, select from pre-set programs and turn the system power on and off.

Chronic pain is a largely under treated and misunderstood disease that affects millions of patients worldwide. It is defined as pain that persists for more than six months after an injury, reoccurs periodically over six months, and continues for an indefinite period of time. As many as one in five people suffers from moderate to severe chronic pain, and one in three people is unable or less able to maintain an independent lifestyle due to pain (according to the World Health Organization in conjunction with The European Federation of 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. ).

The Eon System was approved by the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) in 2005. More than 25,000 patients in more than 25 countries around the world use ANS neurostimulation therapies to manage chronic pain.

About Advanced Neuromodulation Systems

Advanced Neuromodulation Systems (ANS) is 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
. Headquartered 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., the Company employs approximately 10,000 people worldwide. For more information, please visit www.sjm.com.

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 anticipated future product launches, regulatory approvals, revenues, margins, earnings, market shares, and potential clinical success. 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 Cautionary Statements described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21).The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
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Publication:Business Wire
Date:May 8, 2006
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