Clinical results

Chronic high-frequency Deep Brain Stimulation (DBS) in the VIM is efficient and safe in alleviating disabling tremor in Parkinson's Disease and Essential Tremor (P. Limousin et al, JNNP, 1999; 66: 289-296). Based on data from this study, Medtronic received CE-mark for VIM stimulation in uni- and bilateral tremor for Parkinson's Disease and Essential Tremor in Europe in January 1993 and FDA approval for unilateral VIM stimulation.

The above mentioned benefits were stable for at least 6-years as evaluated in a double blind randomized manner (Rehncrona et al, Movement Disorders 2003; 18 (2): 163-170).

In a prospective multi-center study with a randomized, double blind, cross-over evaluation it was shown that bilateral STN or GPi lead placement gave excellent results in improving motor scores and "on" time (The Deep Brain Stimulation for Parkinson's Disease Study Group, N Engl J Med 2001; 345 (13): 956-963). Based on data of this study Medtronic received CE mark for bilateral stimulation of the STN and GpI for Parkinson's Disease in April 1998 and FDA approval for bilateral stimulation was received in Jan 2002.

The Kinetra, a dual channel deep brain stimulation system, is as safe and effective as a single channel neurostimulator (Vesper et al, JNNP, 2002; 73: 275-280). It offers bilateral DBS, but requires implantation of only 1 neurostimulator; so less time in the OR and less trauma for the patient.