The US Food and Drug Administration (FDA) has approved Boston Scientific's Vercise deep-brain stimulation (DBS) system to treat symptoms of Parkinson's disease (PD), the company has announced.
According to Boston Scientific, the Vercise implantable pulse generator is the smallest rechargeable DBS device available in the United States and, depending on individual use, can have a battery life of more than 15 years.
This DBS system has a proprietary capability that independently controls the amount of current delivered by each electrode on the implanted leads, which have eight contacts.
"These system features are designed to work together to address common challenges in DBS therapy ,such as fluctuations in symptoms and the progressive nature of the condition by offering more adaptable delivery of stimulation," the company explains in a news release.
The approval was based on the INTREPID study, a multicenter, prospective, double-blind, randomized, sham-controlled study evaluating the safety and effectiveness of the system in 292 patients with PD at 23 sites.
The study successfully met its primary endpoint of mean change in waking hours with good symptom control. The company expects data from the INTREPID study to be released next year.
Safety data from the European multicenter, prospective, single-arm VANTAGE study also supported FDA approval, the company said. In the VANTAGE study, 40 patients treated with the Vercise DBS system showed a 63% improvement in motor function at 52 weeks from baseline, as measured by the Unified Parkinson's Disease Rating Scale III, as well as improvements in quality of life and medication use.
"The Vercise DBS system changes the landscape of what physicians can do to help improve the quality of life for people living with Parkinson's disease," Jerry Vitek, MD, PhD, professor and chair, Department of Neurology, University of Minnesota Medical School, Minneapolis, and coordinating principal investigator for the INTREPID study, said in the release.
"This system provides an ability to sculpt the current field in the DBS target using novel technology that offers flexibility in programming. This flexibility allows us to target different regions of the subthalamic nucleus, which we believe will improve outcomes while reducing side effects," Dr Vitek said.
Dr Vitek and colleagues will perform the first commercial implant with the Vercise system at the University of Minnesota Medical Center.
"This approval marks an important step for patients who will now have the choice to be treated with one of the most innovative neuromodulation technologies available today," said Maulik Nanavaty, president and senior vice president of neuromodulation for Boston Scientific. "Our system stands apart from the field in its approach and is changing the traditional definition on how we can leverage technology to treat patients with Parkinson's disease."
The Vercise DBS system has been available in Europe since 2012.
Cite this: FDA Clears Deep-Brain Stimulation System for Parkinson's - Medscape - Dec 12, 2017.