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WaveWriter Alpha™ Spinal Cord Stimulator System
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- Overview
- Clinical data
- Technical specifications
- Ordering information
- Training
- Resources
The next era of SCS personalization
Our latest comprehensive spinal cord stimulation (SCS) solution provides uncompromised and personalized solutions with a unified MRI portfolio and all our advanced therapy options, including our proprietary FAST™ Therapy (Fast-Acting Sub-perception Therapy).
How it works
The WaveWriter Alpha SCS System is the most comprehensive SCS portfolio to allow for full-body MRI* access.‡
Why choose the WaveWriter Alpha SCS System
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.
This SCS portfolio features:
- Rechargeable and recharge-free implantable pulse generator options
- The most comprehensive MRI portfolio in SCS
- Future-ready Bluetooth® capabilities
- All of Boston Scientific’s advanced therapies, include our latest proprietary FAST Therapy
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Featured clinical publications
Boston Scientific’s proprietary FAST Therapy delivers profound paresthesia-free pain relief in minutes that is sustained for years.1
SCS device capable of delivery Combination Therapy achieves a high level of clinical and functional success out to 2 years.2
SCS Clinical Data
Multiple Level 1 RCTs and real-world studies support the design of Boston Scientific’s SCS therapy.1-7
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
To explore our comprehensive portfolio of therapies for chronic pain, visit BostonScientific.com/Pain.
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
‡ 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.
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.
- 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.