FDA Approves Deep Brain Stimulation System for Parkinson Disease
The US Food and Drug Administration has approved a new version of the Vercise Genus™ Deep Brain Stimulation (DBS) System for the management of Parkinson disease (PD) symptoms. This is the fourth generation of this DBS system since 2012.
Vercise Genus™ was “approved for conditional use in a magnetic resonance imaging environment,” and “consists of a family of Bluetooth-enabled, rechargeable and nonrechargeable, implantable pulse generators that power Cartesia™ Directional Leads, designed to provide optimal symptom relief,” according to a press release.
The device, which was manufactured by Boston Scientific Corporation, is indicated as an adjunctive therapy in the following scenarios:
- Bilateral stimulation of the subthalamic nucleus to decrease symptoms of moderate to advanced PD that are responsive to levodopa, but are not sufficiently managed with medication.
- Bilateral stimulation of the internal globus pallidus to decrease symptoms of advanced PD that are responsive to levodopa, but are not sufficiently managed with medication.
Boston Scientific receives FDA approval for the Vercise Genus™ deep brain stimulation system. News release. Boston Scientific Corporation; January 22, 2021. Accessed January 22, 2021. https://www.prnewswire.com/news-releases/boston-scientific-receives-fda-approval-for-the-vercise-genus-deep-brain-stimulation-system-301213017.html