Boston Scientific Says INTREPID Study Meets Primary And Secondary Endpoints

(RTTNews) - Boston Scientific Corp. (BSX) announced one-year data from the INTREPID study, the first and only prospective, double-blind, randomized, sham-controlled, multi-center study of deep brain stimulation or DBS for advanced, levodopa-responsive Parkinson's disease or 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 VERCISETM DBS System for the control of symptoms of PD, demonstrated the safety and effectiveness of one of the most innovative additions to the field of DBS in 30 years. DBS is used to treat the symptoms of PD, a degenerative condition that affects more than one million people in the U.S. and 10 million worldwide.

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 or UPDRS III scores compared to pre-surgery screening; 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).