Real-World Data Confirms Significant Pain Reduction Following SPRINT PNS Use with SPR Therapeutics
SPR® Therapeutics announced the publication of a comprehensive real-world retrospective data analysis of over 6,100 patients demonstrating significant pain relief following 60-day percutaneous peripheral nerve stimulation (PNS) treatment with the SPRINT® PNS System in the journal Pain Physician.
Real-world data offer important insights into the effectiveness of a treatment in standard clinical practice outside of a controlled research environment. With a broad range of targeted body regions and peripheral nerves treated, this dataset represents the largest published analysis of PNS outcomes to illustrate the associated improvements on pain and quality of life.
Based on the anonymized data from patients who opted in during their treatment, over 70 percent (4348/6160) of patients were responders with ≥50 percent pain relief and/or improvement in quality of life at the end of treatment. Among these responders, mean percent pain relief was 63 percent, with the majority reporting mild or no pain at the end of treatment. Previously published clinical studies suggest that a majority of responders are likely to experience sustained relief.
The most frequent adverse event reported was skin irritation due to adhesive components with a total rate of adverse events collected from the product complaint database of six percent.
“Seeing impressive real-world results spanning a multitude of nerve targets is significant, especially when considering that these patients may be living with a more challenging list of co-morbidities or conditions than would likely have been allowed for inclusion in prospective clinical trials,” said Marc Huntoon, MD. Dr. Huntoon, SPR’s Director of Medical Affairs, served as the lead author for the study while Director of Pain Management at Virginia Commonwealth University. “In this review of extensive data, there were well over 20 nerve targets in total to address patients experiencing pain throughout the body. The SPRINT PNS treatment performed remarkably well across the gamut of peripheral nerve targets. These data provide the evidence that insurance companies often seek when drafting coverage policy. In this case, the data validates the SPRINT PNS device has similar safety and effectiveness in routine clinical practice compared to clinical studies, complementing prior research further demonstrating that it is not reasonably considered experimental or investigational.”
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