EonC, The First Extended-Life Primary Cell Neurostimulator For The Treatment Of Chronic Pain Approved In USA And Europe

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Aug 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 EonC™, the first extended-life primary cell (non-rechargeable) neurostimulator for the treatment of chronic pain.

The EonC neurostimulator provides a convenient option for chronic pain patients who prefer or require the simplicity of a non-rechargeable medical device. Featuring the greatest battery capacity of any primary cell neurostimulator, the EonC may maximize the time between device replacement procedures.

"Selecting the right system for each patient is vital for the success of spinal cord stimulation (SCS) therapy," said Chris Chavez, president of the St. Jude Medical ANS Division. "With chronic pain, there's no such thing as a 'one size fits all' approach. For some patients, a non-rechargeable device like EonC provides the perfect solution for their needs."

The EonC system's patient benefits include:

- Proprietary technology (called NeuroDynamix™) which helps deliver stimulation with greater efficiency
- Advanced programming capability which allows patients to adjust therapy strength in up to eight pain areas simultaneously and independently
- Constant current circuitry which automatically adjusts power output to deliver consistent therapy over time
- High power and high pulse frequencies which enable clinicians to adjust the therapy to accommodate individual patient needs

EonC is the only 16-contact, constant current, non-rechargeable system for SCS therapy. With the addition of EonC to its product portfolio, ANS now provides an even more comprehensive line of SCS devices to meet the needs of chronic pain patients. The new device complements Eon®, a high-capacity, rechargeable device, and Eon Mini™, the world's smallest, longest-lasting rechargeable neurostimulator.

Neurostimulators like EonC are designed to provide 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 per year in lost work time and health care expenses.

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 more than 12,500 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation.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 Risk Factors and Cautionary Statements sections of the Company's Annual Report on Form 10-K filed on February 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