Healthcare Industry News:  neurostimulator 

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 News Release - November 18, 2009

62-Year-Old Man Becomes First Patient in China Implanted with Rechargeable Neurostimulator for Chronic Pain

St. Jude Medical receives Chinese State Food and Drug Administration approval for Eon and Genesis neurostimulators for chronic pain

ST. PAUL, Minn., Nov 18--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) announced today that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.

The Eon neurostimulator, which is the first rechargeable spinal cord stimulator to be approved for use in China, was recently approved by the Chinese State Food and Drug Administration (SFDA) for the management of chronic low back pain and pain from back surgeries that have failed.

“Chronic pain is a serious health issue in China,” said Professor Zhang De Ren, M.D., an interventional pain physician at the Shenzhen Nanshan Hospital of Shenzhen, Guangdong province who performed the procedure. “We are excited to be able to provide an advanced therapy such as neurostimulation in order to improve patient outcomes.”

The Eon neurostimulator is designed to provide spinal cord stimulation therapy. Similar to a cardiac pacemaker, this “pacemaker for pain” delivers mild electrical pulses to a lead or leads that are placed in the epidural space near the spine to interrupt or mask the transmission of pain signals to the brain. Once activated, the system’s programs are adjusted and fine-tuned to best manage the patient’s pain.

“Implanting the first patient in China with a rechargeable neurostimulator represents an important step toward broadening the availability of this therapy,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “We are proud to provide physicians access to technology that can deliver sustainable relief for chronic pain sufferers who may have exhausted other therapy options.”

Neurostimulation patients can adjust the therapy by using a handheld device (similar to a remote control) that allows them to select from pre-set programs that are individually customized. Patients with a rechargeable Eon neurostimulator periodically recharge their devices, potentially resulting in fewer battery replacement surgeries.

In addition to the Eon rechargeable neurostimulator, the SFDA also approved the non-rechargeable Genesis™ neurostimulator. Non-rechargeable (also known as conventional) neurostimulators provide a convenient option for chronic pain patients who prefer or require the simplicity of a non-rechargeable medical device.

Chronic pain is a largely under-treated and misunderstood disease that affects millions of patients worldwide. The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that as many as one in five people suffers from moderate to severe chronic pain.

More than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation pain therapies at 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 more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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 Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.


Source: St. Jude Medical

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