Healthcare Industry News:  neuromodulation 

Devices Neurosurgery

 News Release - May 27, 2010

St. Jude Medical Announces European Approval for Industry-First Neurostimulation Lead Delivery System for the Management of Chronic Pain

Showcased at the Neurosurgery 2010 Congress, the Next-Generation Epiducer System Allows Introduction of a Unique Perc-Paddle Lead Through a Percutaneous Entry Point

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced European CE Mark approval of its new Epiducer™ lead delivery system for neurostimulation therapy. Unveiled at the Neurosurgery 2010 Congress in Lyon, France, the Epiducer lead delivery system is the first of its kind, allowing introduction of S-Series perc-paddle leads as well as multiple lead arrays through a single percutaneous entry point.

This innovative lead delivery system is designed to reduce procedural complexities. The Epiducer system allows physicians to efficiently place neurostimulation S-Series perc-paddle leads and/or multiple lead arrays utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. Before the Epiducer system, the placement of paddle leads was only possible through a laminotomy, a more invasive surgical procedure, which typically requires removal of part of the vertebral bone.

“One of this system’s advantages is that it enables a physician to introduce a perc-paddle lead into the epidural space with a simpler, less invasive procedure,” said Dr. Olivier De Coster, an anesthesiologist who is head of the Pain Clinic at the Stedelijk Ziekenhuis Hospital in Roeselare, Belgium. “Paddle leads provide numerous therapy benefits including greater stability for reduced risk of migration and more efficient unidirectional stimulation.”

Neurostimulation therapy is used for managing chronic pain of the trunk and limbs and pain from back surgeries that have failed. A paddle lead is a small insulated wire with multiple electrodes on a flat paddle-shaped surface 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.

“We are pleased to provide physicians with this next-generation lead delivery system,” said Chris Chavez, president of the St. Jude Medical neuromodulation Division. “The Epiducer system is redefining percutaneous procedures, presenting physicians with a unique, new option to place leads and reduce procedural complexities.”

Three decades of leading edge neurostimulation technology

For more than 30 years, the St. Jude Medical neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. In the last year alone, the company has introduced 11 new neuromodulation products to aid physicians in the treatment of these conditions. Today more than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.

Some of the innovative products that St. Jude Medical was first to bring to market include:

* World’s smallest neurostimulator for chronic pain – the Eon Mini™ spinal cord stimulator

* Next-generation programming platform used to optimize neurostimulation therapy -- MultiSteering™ technology software for Rapid Programmer™

* First spinal cord stimulator with constant current circuitry – the Genesis™ neurostimulator

* World’s smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson’s disease -- the Brio™ neurostimulator (CE Mark approval)

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 headaches, major depressive disorder, and others.

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.

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 April 3, 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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