FDA Approves Boston Scientific’s Vercise Genus DBS System for Use in MRI Environment
This fourth-generation system since 2012 is indicated as adjunctive therapy for stimulation of the subthalamic nucleus and internal globus pallidus to treat Parkinson symptoms.
Jill Ostrem, MD
Boston Scientific has announced that the FDA has approved its fourth generation Vercise Genus Deep Brain Stimulation (DBS) system for conditional use in a magnetic resonance imaging (MRI) environment.1
The system consists of a group of Bluetooth-enabled implantable pulse generators (IPGs) that power Cartesia Directional Leads, designed to provide optimal symptom relief. They offer both rechargeable and non-rechargeable IPGs, for patient preference.
The Vercise Genus system is the fourth generation of the DBS system since 2012, developed to build on the ongoing innovations being made in battery longevity, directionality, and stimulation capabilities. The system operates in tandem with the Brainlab platform to offer enhanced visualization for clinicians to see lead placement within the context of each patient's segmented target anatomy, Boston Scientific noted.
"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, MD, medical director and division chief, Movement Disorders and Neuromodulation Center, University of California, San Francisco, in a statement. "Now, the latest generation Genus portfolio—with an MR-compatible non-rechargeable IPG as well—provides greater access to patients who might not be candidates for a rechargeable system."
Boston Scientific began its European launch of the system in September 2020, and noted it anticipates its controlled launch in the US to commence in the coming months.
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"The new Vercise Genus DBS System will be a very exciting and welcomed solution for physicians and patients," Rafael Carbunaru, PhD, MSc, vice president, research and development, Neuromodulation, Boston Scientific, told NeurologyLive. "Vercise Genus builds upon our fast pace of meaningful innovations including battery longevity and precise directional stimulation capabilities, which they can get now with a platform that allows patients to have full-body MRI access with both our rechargeable and non-rechargeable options."
The DBS system is currently 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 Parkinson disease which remain uncontrolled with the use of medication. Additionally, it has an indication 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 Parkinson that is not adequately controlled with medication.
This latest approval for the company follows the August 2019 approval of its ImageReady labeling for the Vercise Gevia DBS system, also for use in full-body MRI environments. That system was assessed in the INTREPID trial (NCT01839396), in which its use resulted in a 49.2% improvement in Unified Parkinson’s Disease Rating Scale III (UPDRS III) scores after 12 months.2,3
In May of last year, the company published data from INTREPID that offered class I evidence of its safety and efficacy in the treatment of the motor symptoms of Parkinson disease. The full data showed that from post-implantation baseline to 3 months post-randomization, the difference in mean change in increased on time without troublesome dyskinesias between the active (n = 121) and control (n = 39) groups was 3.03 hours (standard deviation [SD], 4.52; 95% CI, 1.3—4.7; P <.0001).
At the time, study author Jerrold L. Vitek, MD, PhD, professor and head, department of neurology, University of Minnesota, told NeurologyLive that patients in the active arm met the primary outcome, of 3 hours—differing from other studies which have seen more 4 to 4.5 hours. He noted that INTREPID was different, though, in the sense that the investigators assessed patients post-lead implantation.
“The lead itself, just putting it in, can have an effect on patients. Most studies that have been done before this never looked at that. They looked at when patients were screened, before they got implanted—so I got myself screening, I got implanted, I’m out 3 months. How did I look before I got implanted?” he said.
Regarding this recent approval, Maulik Nanavaty, PhD, senior vice president and president, Neuromodulation, Boston Scientific, noted in a statement that the company is committed to prioritizing innovations to improve quality of life for patients with movement disorders. “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," he said.
