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In Brief: Medtronic Activa

This article was originally published in The Gray Sheet

Executive Summary

Medtronic Activa: Implantable neurological stimulation device should be approved for use to suppress tremor associated with essential tremor (ET) and Parkinson's disease, FDA's Neurological Devices Panel concludes in 8-0 vote at March 14 meeting in Rockville, Maryland. Clinical data from an eight-site U.S. study and supplemental European clinicals demonstrate that use of the electrical stimulation system results in a statistically significant decrease in tremor activity and is safe and effective for tremor treatment. While all panel members felt that the data submitted in conjunction with the firm's April 1996 premarket approval application supported single implants, the panel was evenly split (4-4) on approval for bilateral implantation due to limited supporting data for that use...

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