Deep Brain Stimulation System

Vercise Genus™ DBS System clinical data

Review key deep brain stimulation (DBS) study findings that support the design of Boston Scientific’s Vercise Genus DBS System.

DBS therapy backed by extensive clinical evidence

Boston Scientific’s DBS therapy is supported by years of research, including the first multi-center, prospective, double-blind, randomized with sham control trial and comprehensive Real World Outcomes studies in Parkinson’s disease.

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

Class 1 Evidence (RCT)

INTREPID clinical study is the first multi-center, prospective, double-blind, randomized controlled trial with sham control for DBS in Parkinson's disease.

“The outcomes of INTREPID, particularly the remarkable 51% improvement in UPDRS III at 1 year, are among the best results reported for any subthalamic nucleus DBS trial”.

- Günther Deuschl and Paul Krack, The Lancet Neurology Editorial

1-year insights from INTREPID study¹

6 hours

of improvement in ON time without troublesome dyskinesia

51%

improvement in UPDRS III scores

34%

improvement in quality of life

41%

of programs used more than one contact

See the full INTREPID study

Real-World Outcomes in the USA with the Boston Scientific DBS Systems²

Large-scale, on-going registry studies are evaluating effectiveness and safety-related real-world outcomes of a Boston Scientific DBS System. These studies show improvement in symptoms and overall satisfaction with DBS as reflected by the UPDRS III and Global Impression of Change rating scales.

Improvement in motor function at 12 months

Bar chart showing the MDS-UPDRS III Score (Meds-Off) at Baseline and after 12 Months. The Baseline score is 48.7 (n=126), and the 12 Months score is 24.4 (n=45). Asterisk indicates a significant difference between the two time points.

50% sustained improvement was noted in motor function at 12 months (MDS-UPDRS-III).

Global Impression of Change at 12 months

Bar chart comparing the responses of clinicians and patients (n=67) to a treatment. For clinicians: 94% improved, 1.5% no change, 4.5% worse. For patients: 96% improved, 1.5% no change, 3% worse. Color legend: purple for improved, cyan for no change, and dark blue for worse.

96% of patients and 94% clinicians reported improvement following deep brain stimulation (DBS).

See the full Real-World Outcomes in the USA study

Percent improvement in UPDRS III scores compared to literature

Bar chart comparing the percent improvement in UPDRS III scores across different studies. Bars from left to right: Deuschl et al. (41%), Okun et al. (37%), VANTAGE Timmermann et al. (61%), INTREPID Vitek et al. (51%), Vercise DBS Registry Okun et al. (50%).

Real-World Outcomes in Essential Tremor with Boston Scientific DBS Systems⁶

~9 hrs

Hours of tremor reduction post-DBS

12 mo

Months of clinically significant improvement in quality of life

100%

Subjects reporting symptom improvement at 1 year after DBS

See the full Real-World Outcomes in Essential Tremor study

Offer more for your patients by switching to a Vercise Genus Deep Brain Stimulation (DBS) System⁷

68%

patients see an improvement in symptoms or reduction in side effects

100%

patients switched without surgical complications or hardware malfunction

91%

patients programmed using 2 or more contacts

See the full Conversion to Hybrid DBS study

The Vercise™ Adapters are a battery conversion system designed by Boston Scientific for DBS patients with Medtronic® or Abbott® technology. Switching from an existing IPG to a Boston Scientific IPG has been shown to improve patient symptoms or reduce side effects without the need to change a patients’ current wiring.

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Instructions for use

Indications, safety and warnings

References:

Vitek JL, et. al., Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson’s disease (INTREPID): a multicenter, double-blind, randomized, sham-controlled study, The Lancet Neurology, Volume 19, Issue 6, 2020, Pages 491-501.
Okun MS et al. Real-World Outcomes using DBS Systems with Directionality and Multiple Independent Current Control – USA Experience. NANS 2024 Poster.
Deuschl G, Schade-Brittinger C, Krack P, et al. A randomized trial of deep-brain stimulation for Parkinson’s disease. N Engl J Med 2006; 355: 896–908.
Okun MS, Gallo BV, Mandybur G, et al. Subthalamic deep brain stimulation with a constant-current device in Parkinson’s disease: an open-label randomized controlled trial. Lancet Neurol 2012; 11: 140–49.
Timmermann L et. al. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson’s disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study. Lancet Neurol. 2015 Jul;14(7):693-701.
Deuschl G, et al., Prospective, Multicenter, International Registry of Deep Brain Stimulation for Essential Tremor. Poster at Movement Disorders Society (MDS) 2023 Poster.
Ojukwu DI, Wang AR, Hornbeck TS, Lim EA, Sharrard J, Dhall R, Buch VP, Halpern CH. Conversion to Hybrid Deep Brain Stimulation System to Enable Multi-Contact Fractionation Can be Therapeutic. Mov Disord. 2022 Jun;37(6):1321-1323. doi: 10.1002/mds.29007. Epub 2022 Apr 7. PMID: 35393689.

Indications for Use:

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.

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