Implantable neurostimulator WaveWriter Alpha™

for spinal cord stimulationMRI compatiblewireless programmable

Overview
The WaveWriter Alpha™ Spinal Cord Stimulator (SCS) System delivers a configurable portfolio of implantable pulse generators (IPGs), leads and patient controller options to treat chronic pain. Available in 16-contact and 32-contact configurations with rechargeable and non-rechargeable (primary-cell) IPG variants, the system supports full-body MRI conditional access under specified conditions, upgradeable software/firmware, multi-lumen percutaneous leads and paddles, and a discrete mySCS™ GO Therapy Controller for patient adjustment.

Key benefits

• FAST™ Therapy: rapid-onset, paresthesia-free pain relief in minutes for many patients.
• Robust clinical evidence: supported by multiple Level I randomized controlled trials and real-world registry data.
• Comprehensive portfolio: rechargeable and recharge-free IPGs, 16- and 32-contact options, leads and paddles to suit varied anatomy and therapy goals.
• Patient usability: mySCS™ GO Therapy Controller enables discreet, simple therapy adjustments.

Therapies and features

• FAST™ Therapy (sub-perception)
• Contour Therapy
• Illumina 3D™ Standard Rate
• High Rate 3D
• MicroBurst 3D, Burst 3D
• Prism™ Targeting
• Simultaneous combination therapy capability

How FAST Therapy works
FAST engages Surround Inhibition using proprietary targeting and dosing strategies to produce rapid analgesia and improve trial confirmation speed compared with conventional sub-perception approaches.

Clinical data highlights

• Many patients report minutes-to-pain-relief with FAST Therapy during trials and in real-world practice.
• Multiple studies and registries report sustained clinical outcomes at 2–3 years for WaveWriter Alpha therapies, including reductions in pain scores and functional improvement.
• Real-world registries show significant responder rates and maintained benefit at follow-up intervals.

Product literature / usage
Instructions for use, indications, contraindications, safety information and warnings are provided in the product literature included with the device and on the manufacturer's product literature platform. Clinicians should consult these resources prior to implantation and programming.

Ordering information (examples)
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-5275 | 9258388902 | mySCS GO Therapy Controller
SC-6500-72 | M365SC6500720 | WaveWriter Alpha Patient Trial Kit

Technical characteristics / specifications

• Power sources: 16-contact and 32-contact IPG options (rechargeable and non-rechargeable variants across the portfolio).
• Volume: WaveWriter Alpha SCS System 21.6 cc; WaveWriter Alpha 16 = 20.1 cc; WaveWriter Alpha Prime = 36.6 cc; WaveWriter Alpha Prime 16 = 34.9 cc.
• Thickness: WaveWriter Alpha models ~10.7 mm; WaveWriter Alpha Prime models ~11.6 mm.
• Battery type: Rechargeable and primary-cell options depending on model.
• Battery capacity: Rechargeable variants ~200 mAh; non-rechargeable variants ~7 Ah (model dependent).
• Wireless recharging: Available for rechargeable IPGs where applicable.
• Wireless remote / Controller: mySCS™ GO Therapy Controller supported; typical range ~3 m.
• Bluetooth enabled: Yes.
• MRI conditionality: Full-body MRI conditional under specified guidelines and conditions.
• System type: Multiple Independent Current Control (MICC) at 1% increments.
• Regulatory labeling: FDA-cleared for both paresthesia and paresthesia-free therapies (where applicable by model and indication).
• Supported therapies: FAST Therapy, Contour Therapy, Illumina 3D™ Standard Rate, High Rate 3D, MicroBurst 3D, Burst 3D, Prism™ Targeting; simultaneous combination therapy supported.
• Amplitude range: 0–25.5 mA.
• Pulse rate range: 2–1200 Hz.
• Pulse width range: 20–1000 μs.
• Upgradeable: System supports technology upgrades where available.