FDA approves Vercise Genus Deep Brain Stimulation (DBS) System for Parkinsons disease.- Boston Scientific

Boston Scientific has received FDA approval of its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System for Parkinsons disease. The portfolio, approved for conditional use in a magnetic resonance imaging (MRI) environment, consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, implantable pulse generators (IPGs) that power Cartesia Directional Leads, designed to provide optimal symptom relief. It is indicated for use in the bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of moderate to advanced levodopa-responsive PD that are not adequately controlled with medication. The system is also indicated for use in the bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa–responsive PD that are not adequately controlled with medication.