Healthcare Industry News:  deep brain stimulation 

Devices Neurosurgery

 News Release - April 25, 2006

Medtronic to Pursue Major Clinical Trial of Deep Brain Stimulation as Depression Treatment

Results of physician-sponsored studies presented at neurosurgery conference show promise of DBS therapy's positive effect on patients with intractable psychiatric disorders, including OCD

MINNEAPOLIS--(HSMN NewsFeed)--April 25, 2006--Based in part on promising study results presented this week at an international neurosurgical meeting, Medtronic, Inc. (NYSE:MDT ), today announced its intentions to pursue a major clinical trial of the company's deep brain stimulation (DBS) technology in the treatment of severe and intractable depression, a disabling form of the psychiatric disorder affecting millions of people worldwide.

Preliminary plans for the trial, which will involve teams of neurosurgeons and psychiatrists from multiple medical centers, were announced at the American Association of Neurological Surgeons (AANS) meeting in San Francisco.

The announcement follows two AANS presentations about DBS therapy in the treatment of intractable depression and obsessive compulsive disorder (OCD) that were made by Cleveland Clinic neurosurgeon Dr. Ali Rezai. The presentations included clinical data from several physician-sponsored studies supported by Medtronic.

"While not a cure, DBS has allowed these patients to return to much more functional and happy lives," said Dr. Rezai, who represented an international working group of physicians that has been studying the application of DBS therapy in the treatment of intractable depression and OCD in collaboration with Medtronic. (The group includes neurosurgeons and psychiatrists from the Cleveland Clinic, Brown University in Providence, R.I., the University of Florida in Gainesville, the Catholic University of Leuven in Belgium, and the University of Bonn in Germany.)

"These encouraging results will likely lead to further use of DBS in patients with both OCD and depression," added Dr. Rezai.

The pioneer and leader of neurostimulation therapies for movement disorders and chronic pain, Medtronic holds several patents specifically related to the treatment of psychiatric disorders, including depression and OCD. In addition, no other company has a commercially available DBS system approved by the U.S. Food and Drug Administration (FDA). Approved indications for this therapeutic technology include the three major movement disorders - Parkinson's disease, essential tremor and dystonia.

More than 30,000 people worldwide have received DBS therapy with a Medtronic Kinetra® or Soletra® neurostimulation system. More than 50 of these people have taken part in several separate "pilot" studies of DBS therapy as a potential treatment for severely disabling psychiatric disorders, including depression and OCD.

"We are in the process of finalizing our plans for a major clinical trial of DBS therapy as a treatment for chronically severe depression that has not responded to conventional treatments," said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic and former chief scientific officer of the Harvard Clinical Research Institute (HCRI), which he founded. "In collaboration with teams of leading neurosurgeons and psychiatrists, we will be working with the FDA in the coming months to complete a study design that meets the rigors of the agency's review process and our own high standards for evidence of efficacy."

The results of Dr. Rezai's AANS presentations are summarized online at http://www.aans.org/Library/Article.aspx?ArticleId=38034.

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 Quarterly Report on Form 10-Q for the quarter ended January 27, 2006. Actual results may differ materially from anticipated results.


Source: Medtronic

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