Healthcare Industry News: neuromodulation
News Release - July 14, 2009
St. Jude Medical Announces Australian TGA Regulatory Approval for Libra Deep Brain Stimulation Systems for Parkinson's DiseaseST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced Australian Therapeutic Goods Administration (TGA) approval of its Libra(R) and LibraXP(TM) deep brain stimulation (DBS) systems for treating the symptoms of Parkinsonís disease, a neurological disorder that progressively diminishes a personís control over his or her movements.
Similar to a heart pacemaker, the Libra DBS systems function by delivering mild electrical pulses from an implanted device via thin wires with multiple independent electrodes. The stimulation is targeted to one of three regions in the brain which are involved in muscle control for the symptomatic treatment of Parkinsonís disease.
ďThis approval is an important step forward in bringing our deep brain stimulation systems to a broader market,Ē said Chris Chavez, president of the St. Jude Medical neuromodulation Division. ďWe are excited to be able to provide physicians in Australia with these best-in-class deep brain stimulation systems, allowing them to have more capability and control in treating their patients.Ē
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 externally programmed by a clinician to meet individual patient needs.
An estimated 6.3 million people worldwide live with Parkinsonís disease, according to the European Parkinsonís Disease Association. 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, although research suggests that men are two to three times more likely to be diagnosed with the disease than women.
Parkinsonís Disease Symptoms
Parkinsonís disease patients may experience stiffness or rigidity of the arms and legs, slowness or lack of movement, and walking difficulties, in addition to tremor of the hands, arms, legs, jaw or face. These symptoms can make simple, everyday tasks like getting dressed, shaving, eating with utensils and drinking from a glass difficult. Faced with these challenges, Parkinsonís disease patients often have a significant decline in their quality of life.
In addition to the TGA approval, the Libra and LibraXP DBS systems have also received the CE Mark approval in Europe. In the U.S., the systems are currently being evaluated in clinical studies for depression, Parkinsonís disease and essential tremor. For more information about these studies, visit www.BROADENstudy.com, www.PowerOverPD.com and 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 four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.
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 managementís 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 Companyís control and the risk factors and other cautionary statements described in the Companyís filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Companyís 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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