Real-Time Imaging Software for Deep Brain Stimulation Gets FDA Approval

(Editor’s note: This article has been adapted from its original publication on our sister site Neurology Live.)

The Food and Drug Administration (FDA) has approved STIMVIEW XT (Boston Scientific), guided programming software that may offer significant benefits in deep brain stimulation (DBS) procedures for patients with Parkinson’s disease or essential tremor.¹

Utilized in conjunction with the Vercise Genus DBS System, STIMVIEW™ XT offers real-time 3D visualization of brain anatomy that may allow more targeted stimulation modeling and enhanced procedural efficiency in this patient population. One recently published pilot trial revealed that use of STIMVIEW XT helped adjust patient stimulation by an average of 20 minutes, lowering the programming time by 56 percent.²

"It’s exciting that clinicians will now have access to more sophisticated image guided programming tools supporting personalized DBS therapy," noted Jill Ostrem, MD, medical director for the Movement Disorders and Neuromodulation Center at the University of California San Francisco. "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. The fourth generation of the DBS system (with the initial release arriving in 2012) was developed to build on the ongoing innovations being made in battery longevity, directionality, and stimulation capabilities.³

The aforementioned pilot study with STIMVIEW XT was an eight-week randomized crossover trial involving 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 four 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]).²

Additional analyses from that study showed that stimulation settings were not significantly different between the two 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 and president, neuromodulation for Boston Scientific. "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

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

2. 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.

3. Boston Scientific receives FDA approval for the Vercise Genus™ Deep Brain Stimulation System. Boston Scientific. Available at: https://news.bostonscientific.com/2021-01-22-Boston-Scientific-Receives-FDA-Approval-For-The-Vercise-Genus-TM-Deep-Brain-Stimulation-System . Published January 22, 2021. Accessed April 12, 2022.