St. Jude’s neurostim for chronic pain wins Japanese approval

Penta surgical lead is designed to help patients with complex pain patterns such as low back pain

ST. PAUL, Minn., Oct 06, 2011 (BUSINESS WIRE) —

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) of the Penta(TM) surgical lead for neurostimulation therapy to manage chronic pain.

The Penta surgical lead addresses complex pain patterns like low back pain and arm and leg pain. Arranged in five columns, the lead is designed to selectively stimulate nerve fibers associated with the patient’s area of pain without affecting other areas. The Penta lead features a proprietary micro-texturing process that enables greater amounts of current to be delivered via the small electrodes.

The Penta surgical lead can be used with the St. Jude Medical Eon Mini(TM) spinal cord stimulator. Approximately the size of a man’s watch, the Eon Mini neurostimulator’s thin, small design makes it well suited for those patients whose body type requires a small device. In addition to Japan, the Penta lead is also available in the U.S., Europe, Australia and Canada.

"We are proud to be the first in the industry to offer physicians a neurostimulation lead with broad lateral coverage to help patients manage their chronic pain," said William Phillips, president of St. Jude Medical Japan. "The Penta lead provides the most comprehensive spinal cord coverage available, and it is another powerful addition to our expanding line of neurostimulation products."

Chronic pain is a largely under-treated and misunderstood condition 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.

Neurostimulation (also called spinal cord stimulation) is used for managing chronic pain of the trunk and limbs and pain from back surgeries that have failed. Using mild electrical pulses to interrupt or mask the pain signals as they travel to the brain, the neurostimulator can be programmed to meet each individual patient’s needs. More information can be obtained about neurostimulation therapy at www.PowerOverYourPain.com.

Three Decades of Leading-Edge Neurostimulation Technology

For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treatchronic pain and other neurological disorders. Today more than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems. Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Clinical studies are currently underway for Parkinson’s disease, essential tremor, migraine headache, and others.

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. St. Jude Medical is headquartered in St. Paul, Minn., and has four major focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visitsjm.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 January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2011. 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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