Medtronic Kinetra review delayed
This article was originally published in The Gray Sheet
Executive Summary
Additional data on neurostimulator for treating Parkinson's disease and essential tremor have been requested by FDA, firm notes Aug. 12. "We've gone back and redone some of our clinicals...so it's taken us really quite a bit longer than expected," exec Rachael Scherer tells analysts. Previously projected November launch may be "premature," although release still is expected within the fiscal year. Kinetra debuted in Europe in October 1999...