Australian TGA Regulatory And Reimbursement Approval For World's Smallest And Longest-Lasting Rechargeable Neurostimulator To Treat Chronic Pain

Main Category: Pain / Anesthetics
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 25 Feb 2009 - 6:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) today announced Australian Therapeutic Goods Administration (TGA) approval of the Eon Mini™ neurostimulator, the world's smallest, longest-lasting rechargeable device in its class to treat chronic pain of the trunk or limbs and pain from failed back surgery. In Australia, the Eon Mini neurostimulator is reimbursable via the private health system.

Approximately the size of a matchbox, the Eon Mini neurostimulator has a thin 10 mm profile and weighs 29 grams (approximately 1 oz). Its small size allows for a smaller incision, giving the physician more control in selecting the optimal implant location. Additionally, the device has the greatest recommended implant depth of any small rechargeable neurostimulator. For patients, the Eon Mini neurostimulator's thin profile, implant depth and small size allow the device to be placed more discreetly, potentially making it less noticeable and more comfortable.

"Device size and longevity are important considerations for many patients," said John Salmon, M.D., specialist in pain management located at Bethesda Hospital in Perth, Western Australia. "Patients want a therapy that will control their pain, but they don't want the device to be noticeable. Our goal is to provide them with a device that is comfortable, as well as cosmetically appealing, while delivering sustainable therapy for many years."

The Eon Mini neurostimulator is similar in function and appearance to a cardiac pacemaker. It delivers mild electrical pulses to nerves located near the spinal cord to interrupt or mask pain signals as they travel to the brain.

"We are excited to be able to offer a best-in-class product to patients in Australia suffering from chronic pain," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "Eon Mini is designed to provide physicians with more options in selecting a device that best meets the needs of their patients."

The Eon Mini neurostimulator has the longest-lasting battery life of any neurostimulator currently on the market and is the only small rechargeable neurostimulator to receive a 10-year battery longevity approval by the TGA. This means the device should provide sustainable therapy and maintain a reasonable recharge interval for 10 years of use at high settings. The device's battery longevity also may mean that patients require fewer battery replacement surgeries.

The Eon Mini neurostimulator also features:

Enhanced microchip and software (NeuroDynamix™) technology that continuously selects the most efficient power management mode, preserving the battery's capacity to deliver therapy. Constant current circuitry that automatically adjusts power output to deliver consistent therapy over time.

Advanced programming capability that allows physicians to treat up to eight pain areas simultaneously to address complex pain patterns.

A 16-contact device header that is compatible with all St. Jude Medical neurostimulation leads, giving physicians more control in designing the system for optimal pain relief.

Design of the Eon Mini neurostimulator is based on the field-proven platform of the Eon® device and almost three years of performance data and improvements.

According to a report issued jointly by the World Health Organization (WHO) and the International Association for the Study of Pain (IASP), "Chronic pain is one of the most underestimated health care problems in the world today." The report states that "one in five people suffer from moderate to severe chronic pain, and one in three is unable or less able to maintain an independent lifestyle due to pain."

In addition to Australia, the Eon Mini neurostimulation system is available in the U.S. and Europe. More than 45,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation pain therapies at http://www.PowerOverYourPain.com.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit http://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 successes, anticipated regulatory approvals and future product launches, and projected 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 Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

St. Jude Medical