Dr. Bundschu who works out of Bradenton, Fla.-based Coastal Orthopedics, has worked with medical device company Nevro on two studies and produced some of the best results of physicians chosen to validate real-world results using the company’s HF10 technology. Nevro’s HF-SCS at 10kHz has been proven effective in the treatment of chronic back and leg pain in a randomized, controlled trial, but before this study, observational studies had not been performed and published.
A total of 1,660 patients with chronic trunk and/or limb pain were implanted with high-frequency spinal cord stimulation at 10kHz during the Nevro study — a clinical trial to examine the effectiveness of the Silicon Valley-based medical device company’s spinal cord stimulators in treating upper extremity pain.
Patients participating in the study received a temporary stimulator for six-10 days to see if the procedure was for them, and those who elected to proceed received a permanent spinal cord stimulator a few weeks later.
Patients responder rates were evaluated three, six and 12 months post-implantation, and data was collected from eight participating centers in three countries from April 2014 to January 2018.
Every Nevro patient was assigned a patient number and followed through NevroCloud to ensure they received the best results, and at the end of the review, over 70 percent of patients treated with HF-SCS experienced at least 50 percent pain relief throughout the 12-month follow-up period. Most patients also reported an improvement in their quality of life, specifically in terms of function and ability to sleep comfortably.
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