FDA Approves Fourth-Generation Deep Brain Stimulation System for Parkinson Disease Treatment

The Food and Drug Administration (FDA) has approved a fourth-generation deep brain stimulation (DBS) system (Vercise Genus; Boston Scientific Corporation, Marlborough, MA). The DBS device is used to treat symptoms of Parkinson disease (PD) by delivering targeted electrical stimulation through surgically implanted leads in the brain. Devices have the option to be rechargeable or nonrechargeable based on individual preference. Although many individuals prefer long battery life available with a rechargeable system, approximately 80% of DBS devices are nonrechargeable.

"We have used the Vercise Gevia System with the Cartesia Directional Leads to provide our patients with a small device, a battery life of at least 15 years and optimal symptom control by delivering the right dose of stimulation precisely where it's needed," said Jill Ostrem, medical director and division chief, University of California, San Francisco Movement Disorders and Neuromodulation Center. "Now, the latest generation Genus portfolio–with an MR-compatible nonrechargeable implantable pulse generator (IPG) as well–provides greater access to patients who might not be candidates for a rechargeable system."

The DBS system builds upon prompt advances in battery longevity, directionality, and stimulation capabilities. Enhanced visualization capabilities are provided for clinicians to see lead placement within the context of an individual’s segmented target anatomy. 

"We continue to prioritize therapy innovations that improve our patients' quality of life with a wide range of personalized offerings," said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. "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."

The fourth-generation DBS System is expecting to begin a controlled launch in the coming months.