Boston Scientific has obtained approval from the FDA for the fourth generation of its Vercise Genus deep brain stimulation system, allowing conditional use while within an MRI scanner.
Designed to treat the symptoms of Parkinson’s disease such as muscle slowness and tremors, the Vercise Genus family includes Bluetooth-enabled implantable pulse generators with both rechargeable and non-rechargeable models.
The generators connect to the company’s standard Vercise electrical leads or its Cartesia directional leads that allow for more precise stimulation.
"We continue to prioritize therapy innovations that improve our patients' quality of life with a wide range of personalized offerings," Maulik Nanavaty, Ph.D., president of Boston Scientific’s neuromodulation division, said in a statement.
"For people living with movement disorders, this means developing new technologies that are designed to refine motor control, reduce programming times and expand MR compatibility to improve their treatment experience and ultimately their daily living," Nanavaty added. The company launched the Vercise Genus system in Europe last September and plans to begin an initial, limited U.S. rollout in the coming months.
The device was approved for the bilateral stimulation of the brain’s subthalamic nucleus or internal globus pallidus—areas linked to the basal ganglia, which helps control behavior and movement. It’s used as an adjunctive therapy for moderate to advanced Parkinson’s that has been responsive to levodopa treatment, though symptoms are not adequately controlled with medication alone.