CLEVELAND, Jan. 30, 2025 (GLOBE NEWSWIRE) -- SPR announces four featured abstracts that will be presented at the upcoming North American Neuromodulation Society (NANS) Annual Meeting in Orlando, January 29 – February 1. All the abstracts contain recent clinical data and insights highlighting the utility of the SPRINT PNS System in the treatment of pain.
“60-Day PNS vs. Standard Interventional Management for Chronic Low Back Pain (LBP): RESET™ RCT Primary Endpoint Results” (McCormick et al.) reports on the effectiveness of peripheral nerve stimulation (PNS) compared to Standard Interventional Management for chronic low back pain. Millions of Americans experience low back pain annually. Data from this randomized controlled trial* indicate that 60-day percutaneous PNS provided clinically meaningful and statistically superior reductions (greater than or equal to 50 percent) in pain as well as improvements in function and quality of life (p<0.05) at three months after start of treatment and results appear sustained through 12 months post-treatment.
“Bimodal 60-Day PNS Significantly Reduces Shoulder Pain: Outcomes From a Retrospective Multi-Center Chart Review” (Aman et al.) Shoulder pain is one of the most common locations of chronic pain and has the potential to become disabling. Overall, 60-day PNS was shown to be an effective treatment for chronic shoulder pain where 75 percent of patients with available EOT outcome data (n=132/176) reported greater than or equal to 50 percent pain relief. These patients had a variety of shoulder pain causes and treatment histories, with patients receiving Bimodal PNS® stimulation (concurrent motor and sensory stimulation targeting two nerves) producing a significantly higher treatment response rate and mean percent pain relief.
“Percutaneous Peripheral Nerve Stimulation Relieves Persistent Postoperative Pain and Improves Function: Long-term Follow-up from a Double-Blind RCT” (Dickerson et al.) Total knee arthroplasty (TKA) is a common surgical procedure for patients with chronic knee pain whether due to prior injury or aging and deterioration that limits mobility. An estimated 800,000 patients undergo TKA annually in the U.S., and approximately 10-20 percent experience persistent postoperative pain and reduced function. This study’s goal was to characterize the response to 60-day SPRINT PNS compared to sham stimulation (placebo) for postoperative pain following TKA. This multicenter, randomized, double-blind, placebo-controlled trial** demonstrates that the majority of PNS subjects had enduring pain relief and improved physical function from data collected out to 12 months from the start of 60-day percutaneous PNS treatment.
“Durable Improvements in Headache Pain After 60-Day PNS: Six-Month Outcomes of a Prospective Single-Arm Study” (Gutierrez et al.) The MONARCH™ (Multicenter Occipital Neuralgia and Cervicogenic Headache) study was designed to collect prospective data on the safety and efficacy of 60-day PNS targeting the greater occipital nerve and third occipital nerve for the treatment of cervicogenic headache and occipital neuralgia, which are both significant issues for millions of Americans and can be highly disabling conditions. In this IRB-approved, multicenter, prospective, single-arm study, 85 percent of participants (n=17/20) reported greater than or equal to 50 percent reductions in pain and/or pain interference at the EOT with 82 percent (n=14/17) continuing to report greater than or equal to 50 percent reduction in pain intensity and/or interference six months post start of treatment.
See all the abstracts shared at NANS by visiting our summary page here.
The most common adverse events for the SPRINT PNS System in both clinical studies and real-world data include skin irritation and erythema. All four studies (McCormick et al., Aman et al., Dickerson et al., and Gutierrez et al.) reported no study-related serious adverse events.
*The vast majority of funding for this clinical trial was from The Office of the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH-18-1-0800. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
** The vast majority of funding for this clinical trial was from The Office of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Orthopaedic Research Program under Award No. W81XWH1810799. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
Drs. Dickerson, Aman, and Gutierrez are consultants for SPR.
About the SPRINT PNS System
The SPR® SPRINT® PNS System marks an innovative shift in the treatment of pain. Our breakthrough, 60-day treatment is a First-Line PNS™ option uniquely proposed to recondition the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction. The system has been studied extensively for low back pain, knee pain, shoulder pain, post-amputation pain, and chronic and acute postoperative pain, is cleared for use up to 60 days, and is recognized by leading pain management centers. Market research indicates that this breakthrough neuromodulation treatment is a patient-preferred alternative to more invasive options.
The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of postoperative pain. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx only.
For additional information regarding safety and efficacy, visit: SPR Safety Information.
About SPR
SPR is a privately held medical device company, providing patients with a non-opioid, minimally invasive pain treatment option. Our SPRINT® PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and built an incredibly strong foundation for commercial growth. Headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Management team includes experienced industry veterans with nearly 200 years of collective pain market and MedTech expertise, all driven by our purpose – to improve the quality of patients’ lives by providing them with a minimally invasive, drug-free, surgery-free solution to manage their acute and chronic pain. SPR – Solutions for pain. Inspired by life.™
More information can be found at www.SPRPainRelief.com.
SPR Contacts:
Michelle McDonald
Vice President – Marketing
mmcdonald@SPRTherapeutics.com
844.378.9108
Dave Folkens
Public Relations
dfolkens@SPRTherapeutics.com
612.978.6547
