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June 17, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces the first implantation of its Vercise™ DBS System as part of the INTREPID clinical trial. INTREPID is a prospective, multi-center, double-blinded, randomized, controlled study to evaluate the safety and effectiveness of motor function and overall quality of life in patients with the Vercise DBS System for the treatment of Parkinson's disease.
The Vercise DBS System is a neurostimulation device that delivers electrical signals to specific areas within the brain through individual lead contacts. It is the only system that allows physicians to adjust the current flow in fine increments based on patient needs.
The first patient was implanted at Cedars-Sinai in
Los Angeles by a team led by
Michele Tagliati, M.D., director, Movement Disorders Program, and
Adam Mamelak, M.D., FACS, FAANS, director, Functional Neurosurgery.
"The Vercise DBS System offers the promise to customize stimulation control in ways never before possible," said Dr. Tagliati.
"The indications for deep brain stimulation are rapidly expanding, while innovations in the devices used for this therapy have been slower," said
Philip A. Starr, M.D., PhD, co-principal director, Functional Neurosurgery Program,
University of California, San Francisco and co-principal investigator of the trial. "The launch of this trial heralds advanced innovation in device development which is greatly needed."
"The Vercise DBS System has the ability to deliver stimulation in a precise manner due to multiple independent current control which represents a significant opportunity for DBS therapy in the treatment of Parkinson's disease," said
Jerry Vitek, M.D., professor and chair, Department of Neurology,
University of Minnesota and co-principal investigator of the trial. "The technology offered with this system is designed to provide a flexible programming platform that is expected to improve our patients' quality of life."
The Vercise DBS System has both CE Mark and TGA (Australia Therapeutic Goods Administration) approval and is available for sale in
Israel and Australia. In the U.S., the Vercise DBS System is investigational and not available for use or sale.
Parkinson's disease is a progressive neurodegenerative disorder that affects about one million Americans and seven to 10 million people worldwide, according to the World Health Organization and the Parkinson's Disease Foundation.