Boston Scientific has announced the enrollment of first patient in a new clinical registry designed to evaluate outcomes and the economic value of the Vercise deep brain stimulation (DBS) system in Parkinson's disease patients.
The prospective study is anticipated to enroll up approximately 300 Parkinson’s disease patients at hospitals internationally.
Boston Scientific’s Vercise DBS system has the ability to selectively stimulate targeted areas of the brain via multiple independent current control. The system features Zero Volt battery, which the company claims has greater longevity. These features are designed for improved patient outcomes and enhanced clinical effectiveness.
A preliminary analysis of the VANTAGE study showed a mean improvement in motor function of 62.4% for patients at six months post implant, as assessed by the Unified Parkinson’s Disease Rating Scale Part III, when compared to baseline.
VANTAGE is a multi-center, prospective clinical trial for Parkinson’s disease patients implanted with the Vercise DBS system.
Boston Scientific Neuromodulation president Maulik Nanavaty noted that the company is dedicated to supporting clinical research to bring forth innovative technologies that can help improve the quality of life for patients.
"This registry will enable us to provide physicians with a comprehensive, long term view of real world experience and results with the Vercise DBS System for the many patients affected by Parkinson’s disease," Nanavaty added.
Boston Scientific has obtained CE Mark and Australian Therapeutic Goods Administration approval for the Vercise DBS system in 2012. The device is currently available for sale in Europe, Israel, Australia and select countries in Latin America for the treatment of Parkinson’s disease.
The Vercise DBS system has also obtained CE Mark approval in 2013 for the treatment of intractable primary and secondary dystonia. Vercise DBS is an investigational device in the US and is not available for use or sale in the country.
Image: Boston Scientific’s corporate headquarters in Natick, Massachusetts. Photo: Courtesy of Boston Scientific Corporation