Introduction
The WaveWriter Alpha and WaveWriter Alpha Prime Systems are neurostimulation systems designed for the treatment of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back and leg pain, and others.
Device Description
The systems consist of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous leads, Surgical Paddle Leads, Lead Extensions, OR Cables, External Trial Stimulator (ETS), Remote Control, and Clinician Programmer. The systems feature automatic program cycling, MicroBurst capability, programming of multi-areas at rates greater than 130 Hz, patient-provided Therapy Rating, and stimulation electrode field navigation.
Clinical Summary
The safety and effectiveness of the WaveWriter Alpha and WaveWriter Alpha Prime Systems are supported by published clinical studies for similar implanted spinal cord stimulation systems. The systems demonstrated significant reduction in pain and improvement in quality of life in patients with chronic intractable pain of the trunk and/or limbs.
Important Notes
For device-specific information not included in this manual, labeling symbols, and warranty information, refer to the appropriate Device Families User’s Guide (DFU) for your SCS System as listed on your Reference Guide. Additionally, for information on warranties, visit the Boston Scientific website at www.bostonscientific.com/warranty.
Manual:
Download: WaveWriter Alpha and WaveWriter Alpha Prime Systems Information for Prescribers
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