Spectra WaveWriter implantable pulse generator.

Spectra WaveWriter™ Spinal Cord Stimulator System

Name: Spectra WaveWriter™ Spinal Cord Stimulator System - Boston Scientific
Brand: Boston Scientific

The Spectra WaveWriter SCS System is the first SCS system designed to personalize pain relief through the power of the Combination Therapy and the simplicity of waveform automation.

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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
Ordering Information
Training
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Therapy as unique as your patients’ pain

Every patient’s pain is unique. The Spectra WaveWriter Spinal Cord Stimulator System is engineered to help address the individual nature of pain for better short-term and long-term relief.

How it works

Personalized pain relief

With real-time patient therapy ratings and corresponding patient optimization reports, the Spectra WaveWriter SCS System is designed to help you personalize each patient’s therapy and fine-tune your approach as their pain changes over time.

Randomized controlled trials have shown:

There may be different mechanisms involved with different therapies.¹
Some patients may only respond to one therapy.²
Multiple therapies provide superior outcomes when patients are able to choose the most effective therapy.³

Why choose the Spectra WaveWriter SCS System

The Spectra WaveWriter SCS System is designed to simplify personalization and provide the type of stimulation your patients need—when and where they need it.

This SCS system features:

Paresthesia and sub-perception therapies
32 contacts and 4 ports
Leads spanning up to 3 vertebral levels
Combination Therapy for the ability to layer waveforms simultaneously
Contour™ Therapy for broad paresthesia-free coverage across multiple neural targets

Featured clinical publications

COMBO RCT- Combination Therapy Engages Multiple Mechanisms of Action to Provide Excellent Outcomes Compared to Conventional SCS Monotherapy

SCS device capable of delivering Combination Therapy achieves a high level of clinical and functional success out to 2 years.⁵

WAVEWRITER Study- WaveWriter SCS System Delivers Significant and Sustained Pain Relief

Real-world demonstration of WaveWriter SCS System.⁶

SCS clinical data

Multiple Level 1 RCTs and real-world studies support the design of Boston Scientific’s SCS therapy.^{1-5, 9}

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Ordering information

Product Name	Model Number	UPN
Spectra WaveWriter Implantable Pulse Generator (IPG) Kit	SC-1160	M365SC11600
Spectra WaveWriter IPG and Charger Kit	SC-1060B	M365SC1060B0
FreeLink™ Remote Control Kit	SC-5562-1	M365SC556210
Spectra WaveWriter Trial Kit	SC-6500-62	M365SC6500620

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Resources

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

References:

The Precision Spectra™ or Spectra Wave Writer™ SCS System with ImageReady™ MRI Technology is “MR-Conditional” only when exposed to the MRI environment under the specific conditions defined in the ImageReady MRI Guidelines for Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems.

Sub-perception stimulation has been demonstrated to be safe and effective in patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least six months. Full stimulation parameter ranges and options for both paresthesia based and sub-perception therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS.

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

Rauck R, Maoz U, et al. Differential Mechanisms of Action Between Paresthesia and Paresthesia-Free SCS: A PET Study [Abstract]. Annual Meeting of the North American Neuromodulation Society, December 10-13th, 2015.
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.
North J, Loudermilk E, Lee A, Sachdeva H, Kaiafas D, Washabaugh E, Sheth S, Scowcroft J, Mekhail N, Lampert B, Yearwood T, Shaw E, Atallah J, McLeod C, Han J, Yu C, Sedrak M, Lucas R, Trobridge A, Hegarty J, Miller N, Chen L, Jain R. Outcomes of a Multicenter, Prospective, Crossover, Randomized Controlled Trial Evaluating Subperception Spinal Cord Stimulation at ≤1.2 kHz in Previously Implanted Subjects. Neuromodulation. 2020 Jan;23(1):102-108.
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 5CS device capable of delivering combination therapy with advanced waveforms and field shapes. Expert Rev Med Devices. 2020 Sep;17(9):957-957.
Metzger CS, Hammond MB, Paz-Solfs 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,
Paz-Solis J, Thomson S, Jain R, Chen L, Huertas I, Doan Q. Exploration of High- and Low-Frequency Options for Subperception 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 Subperception Spinal Cord Stimulation at s1.2 kHz in Previously Implanted Subjects. Neuromodulation. 2020 Jan;23(7):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):7534-1548.

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