FDA Approves Image Guided Programming Software for Vercise Deep Brain Stimulation Systems

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The fourth-generation deep brain stimulation system is designed to treat the symptoms of Parkinson disease and essential tremor by delivering targeted electrical stimulation via surgically-implanted leads in the brain connected to an implantable pulse generators.

According to an announcement from Boston Scientific, the FDA has approved its Vercise Neural Navigator 5 Software, a software program that is used to set and adjust stimulation parameters for the Vercise Deep Brain Stimulation (DBS) Systems, a previously approved therapeutic approach for patients with Parkinson disease (PD) and essential tremor.1

The newly approved software, with STIMVIEW XT Technology, is the latest addition to the fully integrated portfolio of image guided programming solutions for Boston Scientific DBS Systems. With the Vercise Neural Navigator, clinicians are able to view an enhanced user interface that displays patient data in a simplified format and allows for access to advanced settings for increased therapy delivery.

"The ability to see the precise placement of DBS Systems enables us to target therapy to meet individual needs,” Mustafa Saad Siddiqui, MD, professor of neurology and neurosurgery at Wake Forest School of Medicine and medical director of the DBS program at Atrium Health Wake Forest Baptist, said in a statement.1 "The new features in the Vercise Neural Navigator 5 are expected to help further reduce the time needed to adjust stimulation and minimize potential side effects, allowing us to optimize treatment benefits for each patient."

In 2021, a pilot trial assessing the feasibility of this image-guided programming showed a reduction in programming time without compromising symptom control and patient satisfaction. A total of 10 patients with PD with subthalamic nucleus-DBS were randomly assigned to standard clinical-based programming (CPB) or anatomical-based programming (ABP) in an 8-week crossover study. Results showed that both programs led to similar motor symptom control after 4 weeks (medication OFF/stimulation ON; CPB: 18.27 [±9.23]; ABP: 18.37 [±6.66]) with a 56% reduction in programming time.2

"Developing meaningful tools to help physicians provide personalized treatments for their patients delivers on our promise to advance our technologies for people living with neurological conditions," Jim Cassidy, president of Neuromodulation at Boston Scientific, said in a statement.1 "Providing effective DBS therapy is complex and can be time-consuming. This software will help streamline the process and allow for more doctor-patient interaction time."

The newly approved Neural Navigator is used in conjunction with the STIMVIEW XT guided programming software, which received FDA approval in April 2022, as part of Boston Scientific’s patented product.3 Using patient-specific 3D visualization, STIMVIEW XT empowers DBS programmers to visualize in real-time both lead placement and stimulation modeling of brain anatomy.

READ MORE: FDA Issues Complete Response Letter to Amneal for Parkinson Agent IPX203

The Vercise system consists of a group of Bluetooth-enabled implantable pulse generators 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 made in battery, longevity, directionality, and stimulation capabilities.

At the 2022 American Academy of Neurology Annual Meeting, follow-up data from the INTREPID randomized controlled trial (NCT01839396) showed that treatment with the multi-current DBS system was safe and effective for treating patients with PD up to 4 years. Overall, it led to a 41% improvement in Unified Parkinson’s Disease Rating Scale-III scores compared with screening. Additionally, anti-parkinsonian medication reduction remained stable with sustained improvement in quality of life and treatment satisfaction.4

From the baseline visit to 3 months post randomization, results showed a difference in increased ON time without troublesome dyskinesia of 3.03 hours (SD, 4.52; 95% CI, 1.3-4.7; <.0001). During that time, investigators reported 26 serious adverse events in 20 (13%) patients. Of these, 18 events were reported in the active group and 8 in the control group. Notably, one death was reported among the 196 patients before randomization, which was deemed unrelated to the procedure, device, or stimulation.5 At 1-year compared to presurgery screening, a 49.2% improvement in UPDRS-III scores were reported, and overall improvement in quality of life was maintained.

REFERENCES
1. Boston Scientific receives FDA approval for the next innovation in image guided programming software for deep brain stimulation. News release. July 11, 2023. July 12, 2023. https://news.bostonscientific.com/Boston-Scientific-Receives-FDA-ApprovNext-Innovation-Image-Guided-Programming-Software-Deep-Brain-Stimulation#assets_all
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 recieves FDA approval for next-generation image guided programming software for deep brain stimulation therapy. News release. Boston Scientific. April 12, 2022. Accessed July 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
4. Vitek J, Chen L, Jain R, Starr P. Long-term evaluation of deep brain stimulation for treatment of Parkinson disease using a multiple-source, constant-current system: a 5-year follow-up of a prospective, double-blind RCT. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Abstract 0876
5. Vitek JL, Jain R, Chen L, et al. Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomized, sham-controlled study. Lancet Neurol. 2020;19(6):491-501. doi: 10.1016/S1474-4422(20)30108-3
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