Healthcare Industry News:  neurostimulator 

Devices Neurology Regulatory

 News Release - December 2, 2010

St. Jude Medical Announces New Approvals of Five-Column Neurostimulation Lead to Manage Chronic Pain at 14th Annual North American Neuromodulation Society Meeting

Innovative Penta surgical lead receives European CE Mark and Australian TGA regulatory approvals

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)-- St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced European CE Mark approval and regulatory and reimbursement approval from the Australian Therapeutic Goods Administration (TGA) of its Penta™ surgical lead for neurostimulation therapy.

Highlighted at the 14th annual North American Neuromodulation Society meeting in Las Vegas today, this innovative, five-column surgical lead is the first of its kind, featuring the smallest electrodes on the market. Although the Penta lead is only 10.9 mm wide, it offers the broadest lateral electrode span of any neurostimulation paddle lead. This feature is made possible by a proprietary micro-texturing process that 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 chronic pain.

The Penta lead is also approved for use by the U.S. Food and Drug Administration.

“Early adoption of the Penta lead in the U.S. has been very promising, and we are encouraged by how well this paddle lead is aiding physicians in controlling low back pain,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “We are excited to be able to make this first-of-its-kind product available to physicians in Europe and Australia.”

Spinal cord stimulation therapy, or 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.

“Neurostimulation therapy is often an appropriate choice for patients who have complex pain patterns,” said Dr. Ashwini Sharan, Associate Professor, Department of Neurosurgery and Department of Neurology at Jefferson Medical College and Thomas Jefferson University. “The five-column Penta lead provides the most comprehensive spinal cord coverage available, enabling us to specifically stimulate targeted areas in order to potentially better control the patient’s pain.”

Chronic pain is a largely undertreated 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.

For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to manage chronic pain and other neurological disorders. Today more than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems.

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 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 Report on Form 10-Q for the fiscal quarter ended October 2, 2010. 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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