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Published on 11/1/2005 in the Prospect News Biotech Daily.

Medtronic brain pacemaker trial gets approval to continue from monitoring board

New York, Nov. 1 - Medtronic, Inc. said the U.S. clinical trial for its Intercept epilepsy control system passed an interim review of safety and efficacy data by an independent safety and monitoring board.

With the approval, enrollment in the trial will continue.

The study will further explore the application of Medtronic's already proven neurostimulation technology to reduce seizure frequency and severity in people with difficult-to-treat epilepsy.

"We are encouraged by the board's decision, and are very pleased that the trial will move forward as this pioneering therapy provides hope for so many people who suffer through life with uncontrolled seizures," said Todd Langevin, vice president and general manager, global movement disorders, Medtronic Neurological, said in a news release.

The "brain pacemaker" is being tested at 15 sites in the United States. More than half of the patients needed have been enrolled, Medtronic said. The device could be available for patients in 2008.

Medtronic is a Minneapolis-based medical device maker.


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