Boston Scientific Gets FDA Approval For Vercise Genus DBS System - Quick Facts

(RTTNews) - Boston Scientific Corp. (BSX) announced Friday that it has received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System.

The DBS System 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 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.

DBS devices, specifically the Vercise Genus System, can treat the symptoms of PD by delivering targeted electrical stimulation via surgically-implanted leads in the brain connected to an IPG.

More than 10 million people worldwide are living with Parkinson's disease (PD) - a progressive, neurodegenerative disorder, which causes stiffness, slowness and tremors due to a decrease of dopamine in the brain.

The company commenced the European launch of the Vercise Genus System in September 2020 and expects to begin a controlled U.S. launch in the coming months.