Boston Scientific (NYSE:BSX) announced today that it received FDA approval for its fourth-generation Vercise Genus DBS system.
Marlborough, Mass.-based Boston Scientific’s Vercise Genus deep brain stimulation (DBS) system portfolio is approved for conditional use in a magnetic resonance imaging (MRI) environment. It features a family of Bluetooth-enabled, rechargeable and non-rechargeable implantable pulse generators capable of powering Cartesia directional leads to offer symptom relief for those suffering from Parkinson’s disease, according to a news release.
The fourth generation of the platform, Vercise Genus features increased battery life and improved directionality and stimulation capabilities as the Brainlab platform offers enhanced visualization capabilities for physicians to see lead placement within the context of each patient’s segmented target anatomy.
Vercise Genus is indicated for use in the bilateral stimulation of the subthalamic nucleus as an adjunctive therapy in reducing symptoms of moderate-to-advanced levodopa-responsive Parkinson’s that aren’t adequately controlled with medication. Additionally, the system has indications for use in the bilateral stimulation of the internal globus pallidus.
Boston Scientific launched the Vercise Genus system in Europe in September 2020 and plans to kick off a controlled U.S. launch in the coming months.
“We continue to prioritize therapy innovations that improve our patients’ quality of life with a wide range of personalized offerings,” Boston Scientific senior VP & president of the neuromodulation business Maulik Nanavaty said in the release. “For people living with movement disorders, this means developing new technologies that are designed to refine motor control, reduce programming times and expand MR compatibility to improve their treatment experience and ultimately their daily living.”