Precision Montage implantable pulse generator.

Precision Montage™ MRI Spinal Cord Stimulator System

Name: Precision Montage™ MRI Spinal Cord Stimulator System - Boston Scientific
Brand: Boston Scientific

The Precision Montage MRI SCS System provides access to full-body MRI* scans and delivers multiple waveforms for tailored pain relief, all powered by the Illumina 3D™ algorithm.

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Instructions for use are found inside the product packaging and on our product literature website.

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Directions for use

The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain, Diabetic Peripheral Neuropathy of the lower extremities, radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. The Boston Scientific Spectra WaveWriter™, WaveWriter Alpha™ and WaveWriter Alpha™ Prime SCS Systems are also indicated as an aid in the management of chronic intractable unilateral or bilateral low back and leg pain without prior back surgery. Contraindications, warnings, precautions, side effects. The SCS Systems are contraindicated for patients who: are unable to operate the SCS System, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. Refer to the Instructions for Use provided with the SCS System or Pain.com for potential adverse effects, warnings, and precautions prior to using this product. Warning: Stimulation modes. Only paresthesia-based stimulation mode has been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population.

Overview
Clinical data
Technical specifications
Training
Resources

Multiple waveforms and full-body MRI access

With the Precision Montage MRI SCS System, experience the most advanced programming proven to provide excellent pain relief and full-body MRI access.

How it works

The Illumina 3D algorithm

The Illumina 3D algorithm is designed to customize spinal cord stimulation therapy by delivering multiple waveforms to a precise neural target.

Tailored pain relief is delivered through identifying the:

Right target with the Illumina 3D algorithm
Right waveform with MultiWave™ customized therapy

Why choose the Precision Montage MRI SCS System

The Precision Montage MRI SCS System can accommodate patients requiring access to full-body MRI scans with our full portfolio of leads.

This SCS portfolio features:

Safe, full-body MRI access
Multiple waveforms
The Illumina 3D algorithm

Featured clinical publications

WHISPER RCT- Multiple Treatment Options Provide Superior Outcomes

This Level 1 RCT demonstrates a 74% increase in responder rate when challenging long-term patients can choose their most effective treatment option (paresthesia or paresthesia-free SCS).⁶

LUMINA Study- Illumina 3D Algorithm Delivers Pain Relief Through Precise Targeting

Using a finite-element model of the spinal canal, paresthesia-based SCS provides excellent long-term pain relief.⁷

SCS clinical data

Multiple Level 1 RCTs and real-world studies support the design of Boston Scientific’s SCS therapy.^1-7

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Technical specifications

Feature	Specification
Volume	19.8 cc
Thinness	10.8 mm
MRI safety	Full-body MRI (1.5T)
System type	Independent sources, constant current (MICC)
Power sources	16
Programming	Illumina 3D software
Pulse width	20-1000us
Frequency	2-1,200Hz
Amplitude range	0-25.5mA
Wireless accessories	Yes – FreeLink wireless remote and charger

Education and training for pain medicine

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Resources

To explore our comprehensive portfolio of therapies for chronic pain, visit BostonScientific.com/Pain.

References:

*MRI Conditional under specified conditions

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

Metzger CS, Hammond MB, Paz-Solís JF, et al. A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain. Expert Rev Med Devices. 2021 Mar;18(3):299-306.
Wallace MS, North JM, Phillips GM, et al. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023 Mar;13(3):171-184.
Metzger CS, Hammond MB, Pyles ST, et al. Pain relief outcomes using an SCS device capable of delivering combination therapy with advanced waveforms and field shapes. Expert Rev Med Devices. 2020 Sep;17(9):951-957.
Thomson SJ, Tavakkolizadeh M, Love-Jones S, et al. Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation. 2018 Jan;21(1):67-76.
Paz-Solís J, Thomson S, Jain R, Chen L, Huertas I, Doan Q. Exploration of High- and Low-Frequency Options for Sub-perception Spinal Cord Stimulation Using Neural Dosing Parameter Relationships: The HALO Study. Neuromodulation. 2022 Jan;25(1):94-102
North J, Loudermilk E, Lee A, et al. Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Sub-perception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects. Neuromodulation. 2020 Jan;23(1):102-108.
Veizi E, Hayek SM, North J, et al. Spinal Cord Stimulation (SCS) with Anatomically Guided (3D) Neural Targeting Shows Superior Chronic Axial Low Back Pain Relief Compared to Traditional SCS-LUMINA Study. Pain Med. 2017 Aug 1;18(8):1534-1548.