FDA approves Boston Scientific's fourth-generation Vercise Genus DBS system

Boston Scientific announced Friday that it received FDA approval of its fourth-generation Vercise Genus deep brain stimulation (DBS) system, which features full-body magnetic resonance conditional devices, for the treatment of Parkinson's disease symptoms. The company expects to begin a controlled US launch in the coming months.

The DBS portfolio consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, implantable pulse generators that power Cartesia directional leads, which are designed to provide "optimal" symptom relief, according to the company. Meanwhile, it added that through a strategic collaboration, the Brainlab platform provides "enhanced visualisation," enabling clinicians to see lead placement within each patient's segmented target anatomy.

The fourth-generation Vercise Genus system is indicated as an adjunctive therapy to reduce symptoms of levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Specifically, it is intended for use in bilateral stimulation of the subthalamic nucleus in moderate-to-advanced disease, and in bilateral stimulation of the internal globus pallidus for those with advanced disease.

Boston Scientific commenced the European launch of the DBS system in September 2020.

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