Healthcare Industry News:  neurostimulation 

Devices Neurology Regulatory

 News Release - January 26, 2009

St. Jude Medical Announces European CE Mark Approval for Libra Deep Brain Stimulation Systems for Parkinson's Disease

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced European CE Mark approval of its Libra® and LibraXP™ deep brain stimulation (DBS) systems for treating the symptoms of Parkinson's disease, a neurological disorder that progressively diminishes a person's control over his or her movements and speech. The limited launch of these systems in Europe marks St. Jude Medical's first products in the DBS market.

The Libra DBS systems function in a manner similar to a heart pacemaker by delivering mild electrical pulses from an implanted device to stimulate structures in the brain that are involved in muscle and movement control. Stimulation is delivered to one of two regions in the brain known as the subthalamic nucleus (STN) or the globus pallidus interna (GPi) to influence nerve cell activity in these regions.

“The approval of our first deep brain stimulation system represents the fulfillment of a milestone for St. Jude Medical as we continue to deliver on our promise to develop therapies to treat neurological conditions,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division.

The Libra and LibraXP neurostimulators are constant current devices that feature the largest battery capacity of any DBS device in their class, which may maximize the time between device replacement procedures. This therapy can be non-invasively adjusted by a clinician to meet individual patient needs.

“We have a long history in the development of neurostimulation therapies with more than 45,000 people implanted with our devices for chronic pain,” adds Chavez. “We look forward to providing physicians with this innovative deep brain stimulation system that allows them to better control the symptoms of this debilitating disease.”

Parkinson's disease affects an estimated 6.3 million people worldwide, according to the European Parkinson's Disease Association. Research suggests that men are two to three times more likely to be diagnosed with the disease than women. The National Parkinson's Foundation estimates that 1 in every 100 people in the U.S. over the age of 65 has the disease.

A recent study published in the Journal of the American Medical Association concluded that DBS was a more effective treatment than best medical therapy for the management of moderate to severe Parkinson's disease.

St. Jude Medical is also currently developing new DBS applications to address a growing list of neurological disorders. Clinical studies are underway in the U.S. for depression, Parkinson's disease and essential tremor.

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 approximately 14,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology 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 Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. 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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