Boston Scientific has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise deep brain stimulation system in patients with Parkinson’s disease.
The Vercise deep brain stimulation system is an implantable medical device designed to selectively stimulate targeted areas in the brain, enabling customised therapy and helping improve the quality of life for Parkinson’s disease patients.
The multicentre, prospective study is expected to enrol up to 300 patients with Parkinson’s disease at leading hospitals internationally and will be led by co-principal investigators Gunther Deuschl, director of the Department of Neurology, University Hospital, Kiel, Germany, and Jan Vesper, Department of Functional Neurosurgery and Stereotaxy at Heinrich-Heine University Hospital in Dusseldorf, Germany.
“Parkinson’s disease is a serious and progressive neurological disorder that affects millions of people worldwide. We welcome the opportunity to collect and review a more complete set of data to better understand the clinical impact and the potential of the Vercise deep brain stimulation system to help manage symptoms of Parkinson’s disease,” says Vesper. “The unique features of the Vercise system, including the ability to selectively stimulate targeted areas of the brain via multiple independent current control, as well as the longevity of the Zero Volt battery, are designed for improved patient outcomes and enhanced clinical effectiveness.”
A preliminary analysis of the VANTAGE study, a multicentre, prospective clinical trial for patients with Parkinson’s disease implanted with the Vercise deep brain stimulation system, demonstrated 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.
The Vercise deep brain stimulation system received CE mark approval and Australia Therapeutic Goods Administration approval in 2012 and is available for sale in Europe, Israel, Australia and select countries in Latin America for the treatment of Parkinson’s disease; the system also received CE mark approval for the treatment of intractable primary and secondary dystonia in 2013. In the USA, the Vercise deep brain stimulation system is investigational and not available for use or sale.
