Product Info
Device and Product Description
WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers
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Device and Product Description
The WaveWriter Alpha™ and WaveWriter Alpha™ Prime 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, each
packaged as a separate kit. Single use accessories and disposable tools are also included in these kits.
Features of the WaveWriter Alpha and WaveWriter Alpha Prime System include:
• Automatic program cycling
• MicroBurst capability between 0 to 1 second range
• Programming of multi-areas at rates greater than 130 Hz
• Patient-provided Therapy Rating
• Stimulation electrode eld navigation
• Up to thirty-two independent current-controlled electrodes
• Four programmable stimulation areas per program; sixteen possible programs
• Long-life operation
• High-range parameter capability
• Small size and rounded shape
• Wireless programming capabilities
• This product contains no detectable latex.
Essential Performance
External Trial Stimulator
The stimulation pulse shall meet the requirements for charge balance and amplitude while stimulation is
on.
Other External Devices
Failure of the external electrical components will not result in an unacceptable risk to the user.
System Clinical Summary
Determination of the safety and effectiveness of the WaveWriter Alpha and WaveWriter Alpha Prime
Systems was based on available published clinical studies for similar implanted spinal cord stimulation
systems. The WaveWriter Alpha and WaveWriter Alpha Prime Systems are similar to the SCS systems
reported in published literature in intended use, target patient population, technology, device design, and
output characteristics. Therefore, the clinical data from the published literature described below represents
evidence supporting the safety and effectiveness of the WaveWriter Alpha and WaveWriter Alpha Prime
Systems for the treatment chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral
pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Efcacy Evaluation
Three (3) clinical literature studies were used to support the effectiveness of the WaveWriter Alpha and
WaveWriter Alpha Prime Systems (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach SJ et al.
1995). The studies included a total of 116 patients that were implanted with an SCS system.
A total of approximately 3166 device months of experience was depicted from the retrospective clinical
evaluation. All three studies examined the effectiveness of SCS on patients with chronic pain of the
trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery
syndrome or intractable low back and leg pain. In all studies, a totally implantable spinal cord stimulator
was used in association with a percutaneous and/or surgical lead. These studies provide the same