St. Jude Medical Receives FDA And CE Mark Approvals Of Extended 10-Year Battery Life Claim For Rechargeable Neurostimulator

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics;  Neurology / Neuroscience
Article Date: 15 Feb 2008 - 2:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of a 10-year battery longevity claim for the Eon(R) neurostimulator, a rechargeable device used to treat chronic pain. The announcement was made at the 24th annual meeting of the American Academy of Pain Medicine in Orlando, Fla.

With neurostimulation therapy, devices with rechargeable batteries have quickly become the standard. At high stimulation parameters, a 10-year-old Eon device will maintain at least 24 hours of continuous therapy between recharges. For patients, this means the Eon device can provide sustainable therapy and maintain a reasonable recharge interval for 10 years, potentially resulting in fewer battery replacement surgeries.

Rechargeable neurostimulators are designed with a battery reserve to protect the device from damage should a patient discontinue therapy. The Eon neurostimulator's battery reserve allows the device to be safely recharged for up to 18 months after stimulation has been discontinued.

"We continually strive to develop best-in-class products that enhance patients' quality of life," said Chris Chavez, president of St. Jude Medical's ANS Division. "The addition of battery life-extending technology, which enables the 10-year battery capability, is a prime example of our commitment to making a good product even better."

Introduced in March 2005, the Eon neurostimulator was upgraded in September 2006 with NeuroDynamix™ technology, a proprietary microchip and enhanced software design, which contribute to the increased battery efficiency. The claim was granted after St. Jude Medical monitored the device's performance since the initial product introduction in 2005.

Neurostimulators like the Eon system are designed to provide spinal cord stimulation (SCS) therapy to treat complex neuropathic pain of the trunk and limbs or pain from failed back surgeries. Similar in function and appearance to cardiac pacemakers, these devices deliver mild electrical pulses to the spinal cord, interrupting or masking the pain signals' transmission to the brain. More than 35,000 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.

Pain is a serious and costly public health issue, and it remains largely under-treated and misunderstood. According to the National Institutes of Health, 90 million people in the U.S. suffer from chronic pain. The American Pain Foundation estimates that chronic pain costs approximately $100 billion a year in lost work time and health care expenses.

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 more than 12,000 people worldwide. For more information, please visit http://www.sjm.com.

About the ANS Division of St. Jude Medical

The ANS Division (Advanced Neuromodulation Systems) became part of St. Jude Medical in 2005. The ANS Division 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 (http://www.ans-medical.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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Reports on Form 10-Q filed on August 9, 2007 (see pages 28-29) and November 2, 2007 (see pages 23-24). 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

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