WaveWriter Alpha™ Spinal Cord Stimulator System

The WaveWriter Alpha™ SCS System provides safe access to full-body MRI scans when used with specific components and the patient is exposed to the MRI environment under the defined conditions in the ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator System.  

*MRI Conditional under specified conditions 

‡ ImageReady(TM) MRI Full Body Guidelines for WaveWriter Alpha(TM) and WaveWriter Alpha(TM) Prime Spinal Cord Stimulator Systems. 92395577-02 

MRI Guidelines for Medtronic Neurostimulation Systems for Chronic Pain. M939858A010 Rev C 

1.5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the SENZA®, SENZA II® & SENZA Omnia™ Systems. 11096 Rev J 

MRI Procedure Information For Abbott Medical MR Conditional Neurostimulation Systems. ARTEN600090483 A 

Subperception 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 subperception therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS.  

Gilbert JE, Titus N, Zhang T, Esteller R, Grill WM. Surround Inhibition Mediates Pain Relief by Low Amplitude Spinal Cord Stimulation: Modeling and Measurement. eNeuro. 2022 Oct 5;9(5):ENEURO.0058-22.2022. 

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

The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Boston Scientific Neuromodulation Corporation is under license. 

1. 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.
2. Anitescu M., et al. Clinical Outcomes of a Novel, Fast-Acting Sub-Perception SCS Therapy Engaging Surround Inhibition (FAST Prospective Study) [Abstract]. Twenty-Sixth Annual Meeting of the North American Neuromodulation Society, January 12-15, 2023.
3. Bayerl S., et al. Clinical Outcomes Using A New Fast-Acting Sub-Perception Therapy For Chronic Pain:  A Multicenter European Observational Real-World Study [Abstract]. Twenty-Sixth Annual Meeting of the North American Neuromodulation Society, January 12-15, 2023.
4. 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.
5. 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.
6. 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.
7. Paz-Solís 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
8. North J, Loudermilk E, Lee A, et al. 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.
9. 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.