Study of Vercise DBS System at one year meets endpoint in Parkinsons disease-. Boston Scientific.

Boston Scientific announced one-year data from the INTREPID study, the first and only prospective, double-blind, randomized, sham-controlled, multi-center study of the Vercise DBS System for deep brain stimulation (DBS) for advanced, levodopa-responsive Parkinson's disease (PD) in the United States. The INTREPID study evaluated 292 patients at 23 sites in the U.S. and successfully met its primary and secondary endpoints. The data, which supported the recent U.S. FDA approval of the Vercise DBS System for the control of symptoms of PD, demonstrated the safety and effectiveness of this DBS system.

Highlights of the one-year results include a 49.2 percent improvement in motor symptoms as measured by clinicians in Unified Parkinson's Disease Rating Scale (UPDRS) III scores compared to pre-surgery screening. There was also a six-hour improvement in on time without troublesome dyskinesias as measured by a patient-completed three-day PD diary (motor diary). More than 40 percent of stimulation programs used current that was fractionalized over two or more contacts; and an overall sustained improvement in quality of life as measured by the Parkinson's Disease Questionnaire 39 (PDQ-39). The study is a late-breaking emerging science session presentation at the 70th Annual American Academy of Neurology Meeting.