Summary Box: FDA reviewers say Medtronic missed goal in study of epilepsy treatment
By APWednesday, March 10, 2010
Summary Box: FDA reviews Medtronic stimulator
The Food and Drug Administration has posted its review of a Medtronic device that treats seizures by stimulating areas of the brain used for movement.
UNSTIMULATING RESULTS: The FDA said Medtronic’s study of the device in epilepsy patients missed its goal of showing reduced seizures during a three-month period.
ONE-PATIENT PROBLEM: Medtronic attributed the missed study goal to one patient, who experienced a massive increase in seizures during the month after implantation.
EXPERT OPINION: The FDA will ask a panel of neurological experts this Friday whether Medtronic’s device provides meaningful benefits for patients. The agency is not required to follow their advice.
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