FDA Approves Boston Scientific’s STIMVIEW XT Guided Imaging Software for DBS

Jill Ostrem, MD

The FDA has approved Boston Scientific’s STIMVIEW XT guided programming software, which allows clinicians to visualize in real-time both lead placement and stimulation modeling of brain anatomy for patients with Parkinson disease (PD) or essential tremor who undergo deep brain stimulation (DBS).¹

STIMVIEW XT is used in conjunction with the Vercise Genus DBS System, Boston Scientific’s patented product that received FDA approval in 2021. Using patient-specific 3D visualization, STIMVIEW XT empowers DBS programmers to optimize and deliver directional stimulation more efficiently.

"It’s exciting that clinicians will now have access to more sophisticated image guided programming tools supporting personalized DBS therapy," Jill Ostrem, MD, medical director, Movement Disorders and Neuromodulation Center, University of California San Francisco, said in a statement. "This advancement with STIMVIEW XT may also save time for the clinician as it could help avoid the trial and error in finding the precise location. Prolonged periods of time in adjusting stimulation settings can be stressful and tiring for patients."¹

The Vercise system consists of a group of Bluetooth-enabled implantable pulse generators (IPGs) that power Cartesia Directional leads, designed to provide optimal symptom relief. It is the fourth generation of the DBS system since released in 2012, developed to build on the ongoing innovations being made in battery longevity, directionality, and stimulation capabilities.²

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In a recent study, DBS programmers using STIMVIEW XT were able to program patients in an average of 20 minutes and reduce programming time by 56%. The 8-week crossover trial randomized patients with PD undergoing subthalamic nucleus (STN) DBS to either standard clinical-based programming (CBP) or anatomical-based programming (ABP). In 10 patients, both programs led to similar motor symptom control after 4 weeks, demonstrated by Movement Disorders Society Unified Parkinson’s Disease Rating Scale-III (medication OFF/stimulation ON; CPB: 18.27 [±9.23]; ABP: 18.37 [±6.66]).³

Additional analyses from that study showed that stimulation settings were not significantly different between the 2 approaches, apart from higher frequency in the baseline program than CBP (P = .01) or ABP (P = .0003). Time spent in a program was also not significantly different (CBP: 86.1 [±29.82%]; ABP: 88.6 [±29.0%]).

"Every person’s experience living with Parkinson’s disease or essential tremor is unique, and their treatment should be as unique," said Maulik Nanavaty, senior vice president, Neuromodulation, Boston Scientific, said in a statement. "Our technologies enable clinicians to precisely see, shape, and steer DBS therapy to meet their patients’ individual needs. This latest advancement is a testament to how we’ll continue to deliver on meaningful innovations that support doctors."¹

The Vercise DBS system is currently indicated for use in the bilateral stimulation of the STN and internal globus pallidus as an adjunctive therapy forreducing symptoms of moderate to advanced levodopa-responsive PD which remains not adequately controlled with medication.

In August 2019, the company announced 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 pivotal INTREPID trial (NCT01839396), in which its use resulted in a 49.2% improvement in UPDRS-III scores after 12 months.⁴

REFERENCES
1. Boston Scientific recieves FDA approval for next-generation image guided programming software for deep brain stimulation therapy. News release. Boston Scientific. April 12, 2022. Accessed April 12, 2022. https://news.bostonscientific.com/2022-04-12-Boston-Scientific-Receives-FDA-Approval-for-Next-Generation-Image-Guided-Programming-Software-for-Deep-Brain-Stimulation-Therapy

2. Boston Scientific Receives FDA Approval For The Vercise Genus™ Deep Brain Stimulation System. News release. Boston Scientific. January 22, 2021. Accessed April 12, 2022. https://news.bostonscientific.com/2021-01-22-Boston-Scientific-Receives-FDA-Approval-For-The-Vercise-Genus-TM-Deep-Brain-Stimulation-System

3. Lange F, Steigerwald F, Malzacher T, et al. Reduced programming time and strong symptom control even in chronic course through imaging-based DBS programming. Front Neurol. 2021;12:785529. doi:10.3389/fneur.2021.785529.ecollection 2021.

4. Vitek J, Jain R, Starr P, et. al. A Two-Year Follow-Up of a Prospective, Double Blinded, Multi-Center Randomized Controlled Trial Evaluating Deep Brain Stimulation with a New Multiple Source, Constant-Current Rechargeable System for Treatment of Parkinson's Disease (INTREPID). INS 2019, Sydney, Australia.