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WaveWriter Alpha™ Spinal Cord Stimulator System
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- Overview
- Therapy
- Clinical data
- Technical specifications
- Ordering information
- Training
- Resources
Every minute counts on the journey to pain relief.
Time matters. Why wait?
Boston Scientific offers the broadest SCS portfolio and an exclusive, automated sub-perception therapy that delivers relief in 2 minutes and lasts for years.
How it works
The WaveWriter Alpha SCS System is the most comprehensive SCS portfolio to allow for full-body MRI* access.‡
Why the WaveWriter Alpha SCS System is right for your practice
The WaveWriter Alpha SCS System is a complete solution tailored to meet you and your patients’ needs at every point in the pain management journey.
An SCS portfolio designed for personalized pain relief:
- FAST™ Therapy (Fast-Acting Sub-Perception Therapy) is included in all of Boston Scientific’s advanced therapies, and is the only SCS therapy that delivers paresthesia-free pain relief in minutes that lasts for years
- FAST Therapy allows you to see how your patient is responding before they leave your office
- Our uniquely designed Infinion™ Pro Percutaneous Lead treats multiple areas of pain with a span of 3 vertebral levels and helps mitigate loss of therapy due to lead migration1
- The mySCS GO Therapy Controller is a discrete, easy-to-use remote control that makes adjusting SCS therapy settings simple, safe and secure
- Customizable options that give you flexibility in care with the most comprehensive IPG & lead portfolio in SCS
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FAST™ Therapy delivers profound, paresthesia-free pain relief in minutes that lasts for years
With conventional sub-perception SCS therapy, it takes time to determine whether your patient will experience pain relief.
Every minute counts on the journey to pain relief.
Our proprietary FAST Therapy (Fast-Acting Sub-perception Therapy) is designed to deliver profound, paresthesia-free pain relief in minutes.
Time Matters. Why Wait?
Our latest real-world study demonstrates that patients who preferred FAST Therapy achieved significant pain relief sustained out to 2 years.5
The clinical data behind FAST Therapy
Minutes to Pain Relief2,3†
Pain Score3,4,5†
Year Outcomes4,5,6
Clinical data shows that FAST is
Profound
5.6-point pain score reduction on NRS scale out to 2 years5
29-point improvement in disability on ODI scale out to 2 years5
Preferred
Physicians and patients prefer to achieve pain relief in minutes instead of days3
How FAST Therapy works
Current research indicates that FAST Therapy (Fast-Acting Sub-perception Therapy) engages a distinct SCS mechanism of action called surround inhibition. To experience the benefits of FAST Therapy, there are two key elements: precise targeting, attained with Boston Scientific’s proprietary targeting algorithms, and proper neural dosing with multiple independent current control.
Precise target +
Proper neural dose =
FAST Therapy
Boston Scientific's SCS therapy
Boston Scientific SCS is backed by 4 Level I RCTs and 4 Real-world Studies.8-16
FAST™ Therapy Clinical Data
Unmatched clinical evidence demonstrates that FAST Therapy is:
Featured FAST clinical publications
Boston Scientific's proprietary FAST Therapy delivers profound paresthesia-free pain relief in minutes that is sustained for years.
Metzger C., et al.
Bayerl S., et al.
Anitescu M., et al.
Ferro R., et al.
Technical specifications
| FEATURE | WAVEWRITER ALPHA SCS SYSTEM | WAVEWRITER ALPHA 16 | WAVEWRITER ALPHA PRIME | WAVEWRITER ALPHA PRIME 16 |
|---|---|---|---|---|
| Power Sources | 32 | 16 | 32 | 16 |
| Volume | 21.6cc | 20.1cc | 36.6cc | 34.9cc |
| Thickness | 10.7mm | 10.7mm | 11.6mm | 11.6mm |
| Battery Type | Rechargeable | Rechargeable | Non-Rechargeable | Non-Rechargeable |
| Battery Capacity | 200mAh | 200mAh | 7Ah | 7Ah |
| Wireless Recharging | Yes | Yes | N/A | N/A |
| Wireless Remote | Yes | N/A | ||
| Remote Range | 10 Feet | |||
| Bluetooth Enabled | Yes | |||
| MRI Conditionality | Full Body | |||
| System Type | Multiple Independent Current Control (MICC) at 1% increments | |||
| FDA Labeling | FDA approved for both paresthesia and paresthesia-free therapies | |||
| Advanced Paresthesia and Paresthesia-Free Therapies | FAST Therapy, Contour Therapy, Illumina 3D™ Standard Rate, High Rate 3D, MicroBurst 3D, Burst 3D, Prism™ Targeting | |||
| Simultaneous Combination Therapy | Yes | |||
| Amplitude | 0-25.5mA | |||
| Rate | 2-1200Hz | |||
| Pulse Width | 20-1000μs | |||
| Upgradeable | Yes | |||
Ordering information
| MODEL NUMBER | UPN | DESCRIPTION |
|---|---|---|
| SC-1416 | M365SC14160 | WaveWriter Alpha Prime 16 Implantable Pulse Generator Kit |
| SC-1432 | M365SC14320 | WaveWriter Alpha Prime Implantable Pulse Generator Kit |
| SC-1216 | M365SC12160 | WaveWriter Alpha 16 Implantable Pulse Generator Kit |
| SC-1232 | M365SC12320 | WaveWriter Alpha Implantable Pulse Generator Kit |
| SC-5572-1 | M365SC557210 | FreeLink™ Remote Control Kit |
| SC-6500-72 | M365SC6500720 | WaveWriter Alpha Patient Trial Kit |
| SC-8436-50 | M36SC8436500 | CoverEdge™ MRI 50cm, 32 Contact, 4x8 Surgical Lead Kit |
| SC-8436-70 | M36SC8436700 | CoverEdge MRI 70cm, 32 Contact, 4x8 Surgical Lead Kit |
| SC-8452-50 | M365SC8452500 | CoverEdge X MRI 50cm, 32 Contact, 4x8 Surgical Lead Kit |
| SC-8452-70 | M365SC8452700 | CoverEdge X MRI 70cm, 32 Contact, 4x8 Surgical Lead Kit |
Training for WaveWriter Alpha SCS System
Duration: 40:30
Date: January 2021
Duration: 1:07:15
Date: January 2021
Online medical training and education courses
The EDUCARE online platform makes healthcare education and training more relevant, more comprehensive, more personal, and more accessible. Register to access a library of procedural videos, case studies, training resources, and events.
Resources on ImageReady™ MRI
The WaveWriter Alpha Spinal Cord Stimulator (SCS) System is the most comprehensive portfolio in SCS with full-body MRI* access‡.
Information on expanded indications for SCS
Approved for the treatment of chronic pain associated with DPN
Real-world DPN evidence at 2 years17
A sub-analysis of Boston Scientific's real-world RELIEF registry demonstrated a high responder rate of 81% and 95% sustained improvement at 2 years.16
81% responder rates 95% sustained patient improvement
Approved for the treatment of chronic pain associated with DPN
The SOLIS randomized control trial demonstrates that the WaveWriter Alpha™ SCS System delivered superior outcomes compared to conventional medical management (CMM) alone and sustained outcomes out to one year.15
~90% sustained responder rate over 1-year 86% patient satisfaction in the CMM arm at 3-months
Unlock more targeted treatment options for your chronic pain patients
To explore our comprehensive portfolio of therapies for chronic pain, visit BostonScientific.com/Pain.
Boston Scientific Spinal Cord Stimulator Systems are indicated for use in patients with painful diabetic peripheral neuropathy (DPN) of the lower extremities only with paresthesia-based therapies. FAST™ Therapy and other sub-perception modalities, including Combination Therapy, have not been approved by the FDA for DPN. Do not promote the use of sub-perception modalities with BSC devices in DPN patients. If a prescribing physician decides to use FAST, other sub-perception therapies or Combination Therapy, BSC may provide technical support on the use of the product as directed by the physician.
References:
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
†Disclaimer: These outcomes reflect approximated data as determined in the referenced studies.
‡ ImageReady™ MRI Full Body Guidelines for WaveWriter Alpha™ and WaveWriter Alpha™ 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
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.
FAST MOA computational modeling by 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.
Tsang et al. Reducing surgical interventions using spinal cord stimulation leads providing long span and tight contact spacing. [Abstract] NANS 2025 Annual Meeting, Jan 30-Feb1, 2025. *compared to a wide-spaced 8-contact lead.
Gage E., et al. Rapid Onset of Analgesia during Trial Period Utilizing Fast-Acting Sub-Perception Therapy SCS [Abstract] NANS 2023 Annual Meeting, Jan 12-15, 2023. (n=44)
Anitescu M., et al. Utilizing SCS Designed to Engage Surround Inhibition Using Fast-Acting Sub-Perception Therapy (FAST): Prospective, Multicenter, Long-Term Outcomes [Abstract] NANS 2025 Annual Meeting, Jan 30-Feb 1, 2025.
Metzger C., et al. Two-year Outcomes Using Fast-Acting Sub-perception Therapy for Spinal Cord Stimulation: Results of a Real-World Multicenter Study in the United States. Expert Rev Med Devices. Published online January 2025. (n=50)
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.
Ferro R. et al. Streamlining Spinal Cord Stimulation Therapy via Personalized Automation of Programming [Abstract] NANS 2025 Annual Meeting, Jan 30-Feb 1, 2025. (n=23)
Metzger CS, Hammond MB, Paz-Solis 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.
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;21(1):67-76. (n=20)
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;25(1):94-102. (n=30)
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. 2020:23(1):102-108. (n=140)
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;18(8):1534-1548. (n=169)
Wallace MS, North JM, Phillips GM, et al. Combination therapy with simultaneous delivery of spinal cord stimulation modalities: COMBO randomized controlled trial. Pain Manag. 2023:13(3):171-184. (n=59)
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;17(9):951-957. (n=84)
Metzger C, et al. Long-Term Chronic Pain-Relief Outcomes Using an SCS System Capable of Combination Therapy (WaveWriter Outcomes Study] [Abstract]. Twenty-fifth Annual Meeting of the North American Neuromodulation Society, January 13-15th, 2022. (n=84)
North J., et al. Evaluating SCS and Medical Management for Chronic Pain Without Prior Surgery: SOLIS RCT 24-Month Outcomes [Abstract], NANS 2025 Annual Meeting, Jan 30- Feb l, 2025. (n=77)
Rauck R. et al. Real-World Outcomes Using Spinal Cord Stimulation for Treatment of Chronic Back Pain with No Prior Back Surgery [Abstract 88). Third joint Congress of the INS European Chapters, August 31-September 2nd, 2023, (n=48)
Berg A et al. Global, Multicenter Registry of Prospectively-Enrolled Patients Utilizing SCS for Painful-Diabetic Peripheral Neuropathy (DPN): Long-Term Outcomes [Abstract]. Twenty-seventh Annual Meeting of the North American Neuromodulation Society, January 18-21, 2024.