Healthcare Industry News:  Neurostimulator 

Devices Neurology FDA

 News Release - December 4, 2009

St. Jude Medical Receives FDA Approval for Industry-First Five-Column Neurostimulation Lead to Manage Chronic Pain

Next-generation Penta surgical lead showcased at the 13th Annual North American Neuromodulation Society Meeting

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. market introduction of its new Penta(TM) surgical lead for neurostimulation therapy. Unveiled at the annual North American Neuromodulation Society meeting, the Penta lead is the first of its kind, featuring the smallest electrodes in the market arranged in five columns.

This innovative surgical lead provides the broadest lateral electrode span of any neurostimulation lead on the market – yet the paddle configuration is only 10.9 mm wide. The Penta lead’s unique design is made possible by a proprietary micro-texturing process which enables greater amounts of current to be delivered via the small electrodes. The result is a lead that can more specifically focus current over a greater lateral area of the spinal cord, which may provide better coverage for managing hard to control chronic pain.

“The Penta lead provides surgeons with an innovative new approach to increasing targeted control in managing chronic pain through neurostimulation therapy,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “We are proud to unveil this next-generation surgical lead – yet another first-of-its-kind technological advancement from St. Jude Medical.”

Neurostimulation therapy is used for managing chronic pain of the trunk and limbs and pain from back surgeries that have failed. A lead is a small insulated wire with multiple electrodes that is placed in the epidural space near the spine. Mild electrical pulses are carried from the Neurostimulator to the lead’s electrodes to interrupt or mask the transmission of pain signals to the brain. Electrodes on the lead can be programmed to meet each individual patient’s needs.

Chronic pain affects millions of patients worldwide. In the U.S., more than 76.5 million people are categorized as suffering from chronic pain by the American Pain Foundation. Estimates by the National Institutes of Health place the costs for lost work time and healthcare expenses at approximately $100 billion every year.

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

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

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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