Healthcare Industry News:  deep brain stimulation 

Devices Neurology

 News Release - March 16, 2011

Medtronic Announces Launch of Activa(R) SC Deep Brain Stimulation System

Single-Channel Device Completes Medtronic’s Advanced Activa® Therapy Portfolio for Patients with Movement Disorders

MINNEAPOLIS--(Healthcare Sales & Marketing Network)-- With the first U.S. implant of its new Activa SC neurostimulator for deep brain stimulation (DBS) therapy, Medtronic, Inc. (NYSE:MDT ) today announced the technology’s commercial availability throughout the United States and Europe. The single-channel Activa SC complements Medtronic’s industry-leading Activa PC and Activa RC dual-channel DBS offerings and is the latest addition to the company’s Activa portfolio of DBS systems, the most advanced DBS devices available to treat the symptoms of advanced Parkinson’s disease and essential tremor in the U.S. and Europe. The device is also approved for dystonia in Europe.

The Activa SC system is comprised of an implantable neurostimulator; a thin, insulated lead that is placed in a specific target within the brain; and an extension to connect the neurostimulator and the lead. Like Activa PC, Activa SC is powered by a primary cell (non-rechargeable) battery that does not require maintenance from the patient to provide continuous stimulation for multiple years. An external physician programmer is used to non-invasively adjust stimulation programming parameters, and a hand-held patient programmer with an LCD screen is used by the patient to modify pre-set stimulation settings or check the battery status. Activa SC, like all Medtronic DBS devices, is approved for MRI scans under specified conditions.

“We are excited to be the first institution in the United States to offer Activa SC, an important new technology that greatly enhances our ability to treat and customize therapy for a large group of our patients,” said Richard Simpson, MD, PHD, FACS, professor and attending neurosurgeon, Methodist Neurological Institute in Houston, who implanted the first Activa SC device in the U.S. this week. Activa SC was first introduced in Europe, where the initial implant was performed by Professor Rick Schuurman M.D., at the Academisch Medisch Centrum, University of Amsterdam, The Netherlands.

Medtronic provides the industry’s only complete portfolio of next-generation DBS systems to meet individual patient needs, all in a single programming platform. The advanced programming features of Activa devices provide clinicians with greater ability to fine-tune stimulation and customize their patients’ therapy, which may help patients reach optimized settings sooner.

“More than 15 years since Medtronic DBS Therapy was first introduced, it remains one of the most innovative therapies available for movement disorders,” said Tom Tefft, president of the Neuromodulation business and senior vice president at Medtronic. “The physiology and ongoing treatment requirements of a patient’s symptoms are often as unique as the individual, and we are proud to continue to lead the way in the development of new DBS indications and device innovations – including Activa SC – to improve the management of patients and the outcomes of their DBS therapy.”

More than 80,000 patients worldwide have received Medtronic DBS Therapy, which delivers mild, continuous electrical stimulation from a surgically implanted neurostimulator to precisely targeted areas within the brain. Stimulation of these areas interrupts the brain signals that cause motor symptoms associated with common movement disorders, allowing many individuals to achieve greater control over their body movements.

Medtronic’s Leadership in DBS

Medtronic, in collaboration with leading physicians around the world, pioneered deep brain stimulation therapy, which was first approved in Europe in 1995 and the United States in 1997. Medtronic remains the only company with a commercially available DBS system currently approved by the United States Food and Drug Administration (FDA) and in Europe for management of symptoms of movement disorders, including Parkinson’s disease, essential tremor and dystonia1, and severe, treatment-resistant obsessive-compulsive disorder2 not adequately controlled by medications. In Europe, Medtronic DBS therapy is also approved for the treatment of epilepsy. The company has been involved in more than 2,100 clinical studies3 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 periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

1 Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of dystonia has not been demonstrated.

2 Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated.

3 PubMed Electronic Database of the National Library of Medicine, www.pubmed.gov. Literature search for original clinical studies published between 1993 and May 2009.


Source: Medtronic

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