Nevro Receives FDA Approval to Test Spinal Cord Stimulation Device
announced that the FDA has granted approval for a study evaluating its high-frequency spinal cord stimulation system for the treatment of chronic pain.
The device company's Senza High-Frequency Spinal Cord Stimulation System delivers electrical pulses at a higher rate than devices currently used for spinal cord stimulation, according to the release. Data from previous European clinical studies suggest that this high-frequency waveform may be effective in treating lower back pain and other types of chronic pain that often do not respond to conventional spinal cord stimulation.
The FDA-approved study will consist of a randomized, controlled trial that will enroll approximately 300 patients across up to 15 U.S. centers. Patients will be randomized to receive either Nevro's high-frequency or conventional low-frequency spinal cord stimulation.
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