Healthcare Industry News: neurostimulator
News Release - March 23, 2010
St. Jude Medical Receives Australian TGA Regulatory and Reimbursement Approval for World's Smallest Rechargeable Deep Brain Stimulator for Parkinson's DiseaseSlightly larger than a man’s watch, Brio neurostimulator rounds out St. Jude Medical’s deep brain stimulation product line now available in Australia
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ), a global medical device company, today announced regulatory and reimbursement approval from the Australian Therapeutic Goods Administration (TGA) of its Brio™ deep brain stimulation (DBS) system for treating the symptoms of Parkinson’s disease.
The Brio neurostimulator is the world’s smallest, longest-lasting rechargeable DBS system. Featuring a thin 10 mm profile, the device is slightly larger than the typical man’s watch and weighs 29 grams (approximately 1 oz). In addition to its small size, the Brio neurostimulator has a 10-year battery life approval -- the longest of any rechargeable DBS device currently on the market.
In addition to the regulatory and reimbursement approval of the Brio DBS system, reimbursement authorization was granted for the Libra™ and LibraXP™ non-rechargeable DBS systems, which had received prior TGA approval in 2009.
“The approval of the Brio DBS system in Australia is an exciting addition to our product line that includes the Libra and LibraXP neurostimulators,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “Because we recognize that some patients are better served by rechargeable systems and others with non-rechargeable systems, we are pleased to provide physicians with options that allow them to customize systems to match the patient’s needs.”
The Brio neurostimulator has the greatest implant depth of any rechargeable DBS device available today. The implant depth combined with the device’s thin profile potentially make it less noticeable and more comfortable for patients, while providing physicians with flexibility in selecting the implant location. Additionally, the device is designed with a battery that should provide sustainable therapy while maintaining a reasonable recharge interval for at least 10 years of use at high settings. The device’s battery longevity may also maximize the time between device replacement procedures.
The Brio neurostimulator also features:
* Ability to accommodate two leads, allowing for bilateral stimulation from one device
* High power capability, making it an appropriate choice for patients who require high energy settings to control their symptoms
* A rechargeable battery that can be easily charged through a portable, wireless charging system, allowing patients the freedom to recharge comfortably while doing other activities
* Constant current circuitry that automatically adjusts to deliver consistent therapy over time
Deep brain stimulation is a therapy that uses mild electrical pulses from an implanted device to stimulate specific targets in the brain. The system consists of a neurostimulator – a surgically implanted battery-operated device that generates the electrical pulses – and leads that carry the pulses to the brain to influence the abnormal nerve signals responsible for the symptoms of Parkinson’s disease.
Parkinson’s disease is a chronic, neurodegenerative movement disorder that progressively diminishes a person’s control over his or her movements. The disease affects approximately 6.3 million people worldwide according to the European Parkinson’s Disease Association.
In addition to the TGA approvals, the Brio, Libra and LibraXP DBS systems have also received CE Mark approval in Europe. In the U.S., the Libra and LibraXP systems are currently being evaluated in clinical studies for depression, Parkinson’s disease and essential tremor. For more information about these studies, visit www.BROADENstudy.com, www.PowerOverPD.com and www.PowerOverET.com.
For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. Today, more than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.
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.
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 2, 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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