Healthcare Industry News:  deep brain stimulation 

Devices Neurology FDA

 News Release - May 21, 2009

Medtronic Announces FDA Approval of Two Deep Brain Stimulation Devices That Offer Programming Advances and New Tools for Patients with Movement Disorders

New Devices Are Smallest Available, with One Offering the First-Ever Option of Rechargeability

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ) today announced U.S. Food and Drug Administration (FDA) approval of Activa(R) RC and Activa PC, the most innovative deep brain stimulation (DBS) devices available for the treatment of the symptoms of advanced Parkinson’s disease and essential tremor. Medtronic DBS Therapy delivers small electrical pulses to precisely targeted areas within one or both sides of the brain to help patients achieve greater control over disabling body movements. The new devices will be available in the United States in June.

Both Activa RC and Activa PC devices provide bi-lateral stimulation (to both sides of the brain) and offer a more advanced approach to device programming, and additional tools for capturing history relevant to the patient’s therapy. New programming options provide greater ability to fine tune the stimulation field and give patients more options to optimize their settings compared to previous DBS devices. Additionally, information about patient symptoms and side effects can be stored in the device, which is helpful to physicians in determining the best programming settings for each patient.

These next generation devices also have a hand-held patient programmer, which features new advancements, including an LCD screen that provides valuable information such as the level of battery charge. The programmer allows patients to alternate between stimulation settings pre-programmed by their clinician so they can customize their therapy based on their activity.

“The Activa RC and Activa PC devices offer exciting new programming features that can further enhance the therapeutic benefit of deep brain stimulation for patients with Parkinson’s disease and other movement disorders,” said Leo Verhagen, M.D., Ph.D., medical director of the Surgery Program for Movement Disorders at Rush University Medical Center, Chicago. “This advanced technology will offer more programming features that allow doctors to optimize stimulation effects and also provide options for patients to better control and monitor their therapy settings. For appropriate patients who require high energy settings on their DBS devices, the rechargeable device (Activa RC) may eliminate the need for frequent battery changes.”

Activa PC is powered by a primary cell (non-rechargeable) battery that does not require any regular maintenance from the patient to provide continuous stimulation for multiple years. The Activa PC neurostimulator represents a 20 percent reduction in size and weight compared to previous bi-lateral devices and has similar battery life.

Activa RC is the first and only rechargeable DBS neurostimulator in the world and lasts for nine years before replacement is necessary. Patients need to recharge the device at home on a regular basis depending on their stimulation settings. Activa RC, also significantly smaller than previous bi-lateral devices, is expected to be used for select patients who have high-energy stimulation requirements.

Both Activa RC and Activa PC were approved in Europe in August 2008. Activa PC has become the most widely used device in Europe for bi-lateral DBS therapy.

“Activa RC and Activa PC expand our family of DBS therapy devices to give patients and physicians the flexibility they need to customize a successful DBS treatment program to manage the debilitating symptoms of movement disorders like Parkinson’s disease and essential tremor,” said Richard E. Kuntz, M.D., president of the Neuromodulation business and senior vice president at Medtronic. “These devices also accentuate Medtronic’s place as the long-time pioneer and leader in neuromodulation technology, represented by the only commercially available DBS therapy system in the United States, 20 years of DBS experience, and an ongoing commitment to further pursuit of technological innovations to improve the lives of patients.”

About Medtronic DBS Therapy Medtronic launched DBS in the United States in 1997 for the treatment of essential and Parkinson’s tremor. Since the initial launch of DBS therapy, the list of indications has grown to include management of the symptoms of advanced Parkinson’s disease (approved in 2002), dystonia (approved under a humanitarian device exemption (HDE) in 2003), and obsessive compulsive disorder (approved under an HDE in 2009). To date, more than 60,000 people worldwide have received Medtronic DBS therapy.

The DBS therapy system consists of implantable and external components. Implanted components of the system include the lead, which is a thin coiled wire with electrodes on the end that are placed in a specific target in the brain; the extension wire to connect the lead to the neurostimulator; and the neurostimulator, which, similar to a pacemaker, is placed beneath the skin in the chest and produces the tiny electrical pulses that are believed to block abnormal brain function that causes disabling movements.

External components of the system:
  • Physician programmer: the physician programmer (N-Vision(R)) is used to adjust stimulation programming settings. The electrical pulses can be non-invasively adjusted by a clinician using the physician programmer and transmitted via radio telemetry to the implanted neurostimulator.
  • Patient programmer: the hand-held programmer is used by the patient to turn the neurostimulator off or on, check the battery status, or choose their stimulation settings within a range of options preset by the physician.
  • Activa RC utilizes a wearable charging system which includes the patient controller, recharge antenna, and belt to hold the components in place while re-charging. A patient can move about while recharging, which typically takes a couple of hours every two weeks.
Medtronic’s Leadership in DBS Medtronic, in collaboration with leading physicians around the world, pioneered DBS therapy. The company has been involved in more than 1,500 clinical studies and continues to pursue additional studies today to evaluate the promise of this therapy for other chronic, debilitating neurological conditions.

About Medtronic Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.


Source: Medtronic

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