Study to Evaluate Clinical Outcomes and Economic Value of the Vercise™ Deep Brain Stimulation (DBS) System
Boston Scientific Corporation has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise™ Deep Brain Stimulation (DBS) System in patients with Parkinson's disease.
DBS is a surgical treatment option for patients with movement disorders such as Parkinson's disease (PD), whose symptoms are not adequately controlled with medication. PD is a progressive neurological disorder that affects 6.3 million people worldwide, according to the European Parkinson's Disease Association. The Vercise DBS System is an implantable medical device designed to selectively stimulate targeted areas in the brain, enabling customized therapy and helping improve the quality of life for PD patients.
The multi-center, prospective study is expected to enroll up to 300 patients with PD at leading hospitals internationally and will be led by co-principal investigators Prof. Dr. Gunther Deuschl, director of the Department of Neurology, University Hospital, Kiel, Germany, and Prof. Dr. 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 DBS System to help manage symptoms of Parkinson's disease," said Prof. Dr. 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."
The Vercise clinical registry is an example of the Boston Scientific commitment to advancing science through clinical research. A preliminary analysis of the VANTAGE study, a multi-center, prospective clinical trial for patients with PD implanted with the Vercise DBS System, demonstrated a mean improvement in motor function of 62.4 percent for patients at six months post implant, as assessed by the Unified Parkinson's Disease Rating Scale Part III, when compared to baseline.
"Boston Scientific is dedicated to supporting clinical research to bring forth innovative technologies that can help improve the quality of life for patients," said Maulik Nanavaty, president, Neuromodulation, Boston Scientific. "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."
The Vercise DBS System received CE Mark and TGA (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 for the treatment of intractable primary and secondary dystonia in 2013. In the U.S., the Vercise DBS System is investigational and not available for use or sale.