Rafael Carbunaru, PhD, MSc, vice president, research and development, Neuromodulation, Boston Scientific, discussed the system’s recent FDA approval.
Just a few months after Boston Scientific began its European launch of its Vercise Genus Deep Brain Stimulation (DBS) system in September 2020, the FDA approved the fourth-generation system for conditional use in a magnetic resonance imaging (MRI) environment.1
Boston Scientific noted it anticipates its controlled launch in the US to commence in the coming months. It was developed to build on the ongoing innovations being made in battery longevity, directionality, and stimulation capabilities, and it 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.
Consisting of a group of Bluetooth-enabled implantable pulse generators (IPGs) that power Cartesia Directional Leads, it offers both rechargeable and non-rechargeable IPGs, for patient preference. 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
To further detail the clinical impact of this conditional agency approval, Rafael Carbunaru, PhD, MSc, vice president, research and development, Neuromodulation, Boston Scientific, spoke with NeurologyLive.
Rafael Carbunaru, PhD, MSc: The new Vercise Genus DBS System will be a very exciting and welcomed solution for physicians and patients. 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.
That way, patients and physicians can choose the system that will best adapt to the patient’s needs and choices, without trade-offs. This new generation, our Vercise Genus portfolio – with an MR-conditional non-rechargeable IPG as well – provides greater access to patients who might prefer a non-rechargeable system, which is important because globally, approximately 80 percent of DBS devices used today are non-rechargeable.
In addition, clinicians will find that the Boston Scientific Vercise family of stimulators are specifically designed to control the span and shape of the stimulation in more refined ways than previously possible in deep brain stimulation. This did not come by chance, but by design. For Boston Scientific systems, instead of adapting a pacemaker technology to fit a DBS system, we spent over a decade developing advanced technology to meet the specific needs of the brain and the way it changes. Our proprietary multiple independent current control (MICC) and our new clinician programmers have been designed to provide physicians and patients the precise control to deliver stimulation to the specific areas in the brain in order to optimize their outcomes and adapt to address changes in symptoms during the progression of the condition.
The Vercise Genus 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 Parkinson’s disease (PD) that are not adequately controlled with medication. The system is also indicated 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 PD that is not adequately controlled with medication.
Transcript edited for clarity.