Healthcare Industry News:  neurostimulator 

Devices Neurology

 News Release - June 8, 2009

St. Jude Medical Completes Implants in U.S. Study of Deep Brain Stimulation for Parkinson's Disease

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced the completion of patient implants in its U.S. pivotal clinical study of deep brain stimulation (DBS) for the symptomatic treatment of Parkinson’s disease, a neurological disorder affecting approximately 6.3 million people worldwide that progressively diminishes a person’s control over his or her movements. The announcement was made at the Movement Disorder Society’s 13th International Congress of Parkinson’s Disease and Movement Disorders in Paris.

“We are excited by the progress we’ve made in bringing the Libra® deep brain stimulation systems to the market,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “The completion of patient implants in this study and our recent European CE Mark approval represent significant steps towards our goal of providing physicians with an innovative deep brain stimulation system for treating Parkinson’s disease.”

Ongoing at 15 medical centers in the U.S., this randomized, controlled study is evaluating the St. Jude Medical Libra and LibraXP™ DBS systems, to determine the devices’ safety and effectiveness in controlling many of the motor symptoms of advanced Parkinson’s disease. The study is following 136 participants who have lived with the disease for more than five years and whose symptoms were insufficiently controlled with medication alone.

“Ultimately patients benefit from the development of new technologies,” said Michele Tagliati, M.D., associate professor of neurology and division chief of movement disorders at Mount Sinai Medical Center in New York who enrolled the first patient in the study. “We are hopeful the Libra deep brain stimulation systems will prove effective at reducing the symptoms of Parkinson’s disease and provide additional tools to better control this debilitating condition.”

The Libra and LibraXP neurostimulators are constant current devices. 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 progressive nature of Parkinson’s disease often leads patients to a point where medication management alone can no longer adequately control the symptoms of the disease,” said Bruno Gallo, M.D., assistant professor of neurology at the University of Miami in Florida and an investigator in the study. “Because these patients often become unable to care for themselves, we need to look for additional methods of treating this debilitating condition in order to help improve a patient’s quality of life.”

The National Parkinson Foundation (www.Parkinson.org) estimates that in the United States, more than 1.5 million people currently have the disease with 60,000 new cases diagnosed each year. According to the European Parkinson’s Disease Association, as many as 6.3 million people are estimated to be affected by this disease worldwide.

For additional information about this study, visit www.PowerOverPD.com. 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 and essential tremor. For more information about these studies, visit www.BROADENstudy.com and www.PowerOverET.com.

More than 45,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems. For more information about St. Jude Medical pain therapies, visit www.PowerOverYourPain.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 four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit 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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 4, 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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