Medtronic's DBS approval delayed
This article was originally published in The Gray Sheet
Executive Summary
PMA approval for Medtronic's DBS system for treatment of epilepsy may be delayed following a recent FDA request for additional data, which will require further clinical study. In March, FDA's Neurological Devices Panel recommended approval with conditions for the deep brain stimulation device, and the firm had predicted last November that it could receive PMA approval by this summer (1"The Gray Sheet" March 15, 2010). FDA's new data request will likely push out PMA approval by two to three years, JP Morgan analyst Michael Weinstein said in a Sept. 16 report. On Sept. 16, Medtronic announced it had received a CE mark for the DBS system to treat epilepsy; the firm will launch the device in Europe by the end of the year
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