St. Jude Medical Announces First European Patient Implants Of The Libra Deep Brain Stimulation Systems For Parkinson's Disease

Main Category: Parkinson's Disease
Also Included In: Neurology / Neuroscience
Article Date: 29 Mar 2009 - 1:00 PDT

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St. Jude Medical, Inc. (NYSE:STJ) announced the first patient implants of its Libra® deep brain stimulation (DBS) system for treating the symptoms of Parkinson's disease, a progressive neurological disorder that affects a person's control over his or her movements and speech. The announcement was made at the European Association of Neurosurgical Societies and the Société Française de Neurochirugie joint annual meeting in Marseille, France.

"We have initiated a limited launch of these systems in Europe and have recently completed implants in Austria, Germany and Greece," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "We look forward to expanding the availability of these systems in order to help physicians meet the needs of their patients."

First implants were performed by Professor François Alesch, M.D., at the Medical University of Vienna, Vienna Austria, Professor Jan Vesper, M.D., at the University of Düsseldorf, Düsseldorf, Germany, and Professor Damianos Sakas, M.D., at the Evangelismos General Hospital, Athens, Greece.

"Deep brain stimulation is a safe surgical treatment for advanced Parkinson's disease," said Dr. Alesch, a professor of Stereotactic and Functional Neurosurgery at the Medical University of Vienna. "The availability of the Libra DBS systems allows us to choose the system that best meets the needs of the individual patient."

The European Parkinson's Disease Association estimates that Parkinson's disease affects approximately 6.3 million people worldwide. The disease usually develops in people between the ages of 40 and 70, with an average age of onset of 60 years. Parkinson's disease affects both men and women in almost equal numbers.

"In properly selected patients, deep brain stimulation therapy can provide extremely good results," said Professor Alfons Schnitzler, M.D., at the University of Düsseldorf. "For these patients, DBS may reduce akinesia, rigidity, tremor and levodopa-induced motor complications resulting in a significant improvement in their quality of life."

The Libra and LibraXP™ neurostimulators are constant current devices and feature the highest battery capacity of any DBS devices in their class, which may maximize the time between device replacement procedures. The systems consist of a neurostimulator - a surgically implanted battery operated device that generates mild electrical pulses - and leads which carry the pulses to a targeted area in the brain. The system functions in a manner similar to a cardiac pacemaker by influencing the irregular nerve signals responsible for the symptoms of Parkinson's disease. This therapy can be non-invasively adjusted by a clinician to meet individual patient needs.

The European CE Mark approvals of the Libra and LibraXP DBS systems represent the first deep brain stimulation system approvals for St. Jude Medical. Additionally, St. Jude Medical is developing other DBS applications to address a growing list of neurological disorders. DBS clinical studies are underway in the U.S. for depression, Parkinson's disease and essential tremor. For more information about these studies, visit http://www.BROADENstudy.com, http://www.PowerOverPD.com and http://www.PowerOverET.com.

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 http://www.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 Annual Report on Form 10-K for the fiscal year ended January 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.

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St. Jude Medical