Nevro Corp out of Menlo Park, California received the go ahead from the FDA to begin a clinical trial of the company’s Nevro Senza high-frequency spinal cord stimulation system for chronic pain treatment. The Senza delivers electrical signals around the spinal cord at a frequency higher than traditional stimulators.
According to a previous European clinical trial on the Senza techcnology, the system may be more effective in certain patients over traditional stimulators, and the common side effect of paresthesia (feeling of pins and needles such as when a limb “falls asleep”) seems to be totally absent thanks to the high frequency signal, which means surgeons won’t have to perform paresthesia mapping in the operating room.
- 8 contact leads
- External trial stimulator, which mimics the output of the implantable pulse generator (IPG)
- Patient remote control
- Clinician programmer
- Portable recharging system
- Various accessories such as lead extensions
Press release: Nevro Receives FDA Approval to Initiate Landmark U.S. Randomized Pivotal Trial of Innovative Chronic Pain Treatment…
Product page: Nevro Senza…