Deep Brain Stimulation System

Outcomes Matter: Image Guided Programming and Therapy Options Clinical Data

Review key clinical studies supporting the advancement of Boston Scientific’s Image Guided Programming and Deep Brain Stimulation (DBS) therapy options.

Personalized DBS therapy made possible through years of clinical research

Supported by years of research and ongoing clinical studies, Boston Scientific has the most DBS therapy options* available, including semi-bipolar and anodic stimulation capabilities. These options, combined with our Image Guided Programming, enable you to save time and optimize outcomes for each of your patients.

To get answers to your questions and additional information on Boston Scientific’s DBS System, contact a DBS sales representative.

Image Guided Programming clinical data

Boston Scientific’s Image Guided Programming makes it easier and more efficient to personalize every aspect of your patient’s DBS journey.

Reduced programming time and strong symptom control with Image Guided Programming¹

A double blind, cross-over, randomized controlled trial comparing Clinical-Based Programming (CBP) to Anatomy-Based (Image-Guided) Programming (ABP)¹ with Vercise™ Deep Brain Stimulation System demonstrated a 56% reduction in programming time with equivalent long-term improvement in motor outcomes.

Saves Time

Bar graph comparing programming time in minutes. Conventional programming shows approximately 50 minutes, while image guided programming shows approximately 25 minutes. Error bars are included.

Time needed for directional monopolar review vs.
anatomy-based programming

56%

reduction in programming time with equivalent long-term improvements in motor outcomes with Image Guided Programming (n = 10)**

See the full CBP compared to ABP study

Image Guided programming improves clinical outcomes in patients with Parkinson's disease

84% of patients

experienced lasting Motor and Quality of Life improvements after being re-programmed using Image Guided Programming (n=31)²

81%

of patients had an incremental improvement in PDQ-8 (Quality of Life)²

55%

of patients had a clinically meaningful improvement of at least 5 points in UPDRS-III (Motor symptoms)^2,3

29%

of patients had incremental reductions in levodopa equivalent daily dosage²

See full clinical outcomes study

Image Guided Programming reduces programming time and allows for stable settings over time⁴

This Real-World Outcomes study analyzed the real-world clinical use of Image Guided Programming during initial programming sessions of patients with Parkinson’s disease (11 centers).

Image Guided Programming makes initial programming visits efficient, while providing stable settings that results in motor function improvement.

Initial programming time of directional leads

Bar chart depicting the time for initial programming of directional leads among 56 subjects: 31 subjects took less than 30 minutes, 16 took 30-60 minutes, and 9 took more than 60 minutes.

72%

reduction in initial programming time compared to reported averages

Image-Guided Programming allows for Sustained Settings Long -Term

92%

average stimulation field model overlap between initial programming and 1-year follow up (n = 18) with Image Guided Programming

Example image of overlap between initial programming (red), 6-months (green), and 1-year follow-up (blue)

Example image of overalp between initial programming (red), 6-months (green), and 1 year-follow up (blue)

See the full Image Guided Programming study

See DBS from every angle

Image Guided Programming makes delivering directional stimulation easier and more efficient.

Learn more about Boston Scientific Image Guided Programming

DBS therapy options clinical data

Manage side effects as your patient’s disease progresses with the most therapy options* available. Anodic and semi-bipolar stimulation capabilities are only available with Boston Scientific and enable you to personalize DBS therapy for each of your patients.

Anodic Versus Cathodic Neurostimulation of the Subthalamic Nucleus: A Randomized-Controlled Study of Acute Clinical Effects⁵

Clinical effect and side effect thresholds

Clinical effect thresholds and side effect thresholds for both cathodic and anodic stimulation are shown. Clinical effect thresholds increased from 1.99 ± 1.37 mA for cathodic stimulation to 3.36 ±1.58 mA for anodic stimulation (p < 0.0001)‡ while side effect thresholds also increased from 4.15 ± 1.13 mA for cathodic stimulation to 6.05 ±1.52 mA for anodic stimulation (p < 0.0001)‡.

See the full Anodic Versus Cathodic Neurostimulation study

Bipolar Directional Deep Brain Stimulation in Essential and Parkinsonian Tremor⁶

In a prospective, double-blind study (n=14), bipolar stimulation allowed for higher stimulation amplitudes without side effects compared to monopolar directional stimulation.

All conditions showed comparable therapeutic effects.

Side effect frequency based on stimulation type

A bar chart showing the frequency of side effects within amplitude range for three types of electrical stimulation: Direct (12), Bipolar (5), and Bi-direct (2). The bars for Direct, Bipolar, and Bi-direct are in cyan, purple, and dark blue, respectively.

83%

of the patients saw improvement in side effects when using bipolar directional stimulation

See the full Bipolar Directional DBS study

Unique stimulation capabilities only available with Boston Scientific

Vercise™ Neural Navigator 5 Software with Image Guided Programming makes it easier to personalize your patients' DBS journey.

Learn more about Vercise Neural Navigator 5

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Instructions for use

Indications, safety and warnings

References:

Lange F, Et al. Reduced Programming Time and Strong Symptom Control Even in Chronic Course Through Imaging-Based DBS Programming. Front Neurol. 2021 Nov 8;12:785529. N=10.
Torres V et al. Image-guided programming deep brain stimulation improves clinical outcomes in patients with Parkinson’s disease. npj Parkinsons Dis. 10, 29 (2024).
Sánchez-Ferro Á et al. Minimal Clinically Important Difference for UPDRS-III in Daily Practice. Mov Disord Clin Pract. 2018 Jun 26;5(4):448-450.
Aldred et al. (2023). Image-Guided Programming Tool for DBS Programming Reduces Initial DBS Programming Time and Allows for Sustained Settings Long-Term. MDS 2023 Poster.
Kirsch AD, Hassin-Baer S, Matthies C, Volkmann J, Steigerwald F. Anodic versus cathodic neurostimulation of the subthalamic nucleus: A randomized-controlled study of acute clinical effects. Parkinsonism Relat Disord. 2018 Oct;55:61-67. doi: 10.1016/j.parkreldis.2018.05.015. Epub 2018 May 16. PMID: 29784559.
Steffen JK et al. Bipolar Directional Deep Brain Stimulation in Essential and Parkinsonian Tremor. Neuromodulation. 2020 Jun;23(4):543-549. doi: 10.1111/ner.13109. Epub 2020 Feb 10. PMID: 32040883.

Indications for Use:

* Information for competitive devices excerpted from the literature published by Medtronic (M982261A015 Rev A, M939241A051 Rev A, M013074C001 Rev B, M982097A013 Rev A, M13075C001 Rev B, M019192C002 Rev A) and Abbott (ARTEN600150429 - B, ARTEN600102238 - A, ARTEN600266398 -A, ARTEN600308953 -A, ARTEN600308947 -A), and Schüpbach, Michael & Chabardes, Stephan & Matthies, Cordula & Pollo, Claudio & Steigerwald, Frank & Timmermann, Lars & Vandewalle, Veerle & Volkmann, Jens & Schuurman, P.. (2017). Directional leads for deep brain stimulation: Opportunities and challenges. Movement Disorders. 32. 10.1002/mds.27096.
Steffen, J. K., Reker, P., Mennicken, F. K., Dembek, T. A., Dafsari, H. S., Fink, G. R., Visser-Vandewalle, V., & Barbe, M. T. (2020). Bipolar Directional Deep Brain Stimulation in Essential and Parkinsonian Tremor. Neuromodulation: Technology at the Neural Interface, 23(4), 543–549. DOI: 10.1111/ner.13109
Reker, P., Dembek, T. A., Becker, J., Visser-Vandewalle, V., & Timmermann, L. (2016). Directional deep brain stimulation: A case of avoiding dysarthria with bipolar directional current steering. Parkinsonism & Related Disorders, 31, 156-158. https://doi.org/10.1016/j.parkreldis.2016.08.007
Kirsch, A. D., Hassin-Baer, S., Matthies, C., Volkmann, J., & Steigerwald, F. (2018). Anodic versus cathodic neurostimulation of the subthalamic nucleus: A randomized-controlled study of acute clinical effects. Parkinsonism & Related Disorders, 55, 61-67. https://doi.org/10.1016/j.parkreldis.2018.05.015.
Boston Scientific (Vercise ™ Neural Navigator 5 Software Programming Manual MP92736308-01).

**Image Guided programming in PD patients enables a reduction in programming time compared with standard clinical based programming (p=39).

Lange F, Et al. Reduced Programming Time and Strong Symptom Control Even in Chronic Course Through Imaging-Based DBS Programming. Front Neurol. 2021 Nov 8;12:785529. N=10

Results from clinical studies are not predictive of results in other studies. Results in other studies may vary.

Indication for Use: The Boston Scientific Vercise™ PC, Vercise Gevia™, Vercise Genus™ Deep Brain Stimulation Systems are indicated for use in:
-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.
-Bilateral stimulation of the internal globus pallidus (GPi) as an adjunctive therapy in reducing some of the symptoms of advanced levodopa-responsive Parkinson’s disease (PD) that are not adequately controlled with medication.
-Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.
-Bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.

The Boston Scientific Vercise Deep Brain Stimulation System is indicated for use in:
-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.

Contraindications, warnings, precautions, side effects: The Boston Scientific Deep Brain Stimulation (DBS) Systems or any of its components, are contraindicated for: Diathermy as either a treatment for a medical condition or as part of a surgical procedure, Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation (TMS) as the safety of these therapies in patients implanted with the Boston Scientific DBS System has not been established, patients who are unable to operate the system, patients who are poor surgical candidates or who experience unsuccessful test stimulation. Patients implanted with Boston Scientific DBS System without ImageReady™ MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Patients implanted with Vercise Gevia or Vercise Genus or Vercise Genus Mixed System with M8 Adapter or Vercise DBS Lead-Only System (before Stimulator is implanted) with ImageReady MRI Technology are Full Body MR Conditional only when exposed to the MRI environment under the specific conditions defined in ImageReady MRI Guidelines for Boston Scientific DBS Systems. Assess patients for the risks of depression and suicide. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy. Monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control and manage appropriately. Refer to the Instructions for Use provided with the Boston Scientific DBS Systems or BostonScientific.com for potential adverse effects, warnings, and precautions prior to using this product. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.