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.

—Christina Vogt

Reference:
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