Three Posters Accepted Including a President’s Choice Award for New Data from a Randomized Controlled Trial on Total Knee Replacement Postoperative Pain
CLEVELAND, Nov. 13, 2023 (GLOBE NEWSWIRE) — At the 22nd Annual American Society of Regional Anesthesia (ASRA) Pain Medicine Meeting in New Orleans, three posters on the SPRINT® PNS System were shared for the first time.
The first poster, “Percutaneous PNS Relieves Persistent Postoperative Pain and Improves Function after TKA: Results from a Placebo-Controlled Randomized Controlled Trial” was recognized with a President’s Choice Award from ASRA. This poster highlights the results from a prospective trial evaluating the impact of SPRINT peripheral nerve stimulation (PNS) used for chronic knee pain after total knee arthroplasty (TKA) surgery. Not only did this study demonstrate that the majority (60 percent) of the SPRINT PNS treatment group (n=12/20) experienced ≥50 percent pain relief at End of Treatment compared to baseline, it also provided objective functional data measured with a six-minute walk test. The SPRINT PNS treatment group (n=18) demonstrated a 47 percent improvement in walking ability measured by a six-minute walk test whereas the placebo group (n=20) demonstrated a nine percent decrease. This is an important finding for the large number of TKA patients who experience ongoing postoperative TKA neuropathic pain (up to 20 percent of the 800,000 patients undergoing TKA surgery annually in the U.S.). There were no study-related serious or unanticipated adverse events.
The second poster, “60-day PNS for Pain Management in a Medicare-Eligible Population: Real-World Outcomes from a Retrospective Analysis” is a review of outcomes in a subset of 1,763 Medicare eligible patients from the recently published SPRINT PNS real-world retrospective data of over 6,000 patients. The Medicare eligible population is an important one as a reported 78 percent of Medicare beneficiaries may experience chronic pain, and this retrospective review supports the use of 60-day PNS as a safe and effective option for chronic pain management in the Medicare-eligible population. In this retrospective analysis, 70 percent of patients (n=1,226/1,763) were defined as responders at End of Treatment (≥50 percent pain relief and/or clinically significant improvement of ≥1 in Patient Global Impression of Change) across all nerve targets, consistent with recent prospective studies. The total rate of reported adverse events for this Medicare-eligible cohort was four percent, with the most frequent event being skin irritation, typically due to bandages or adhesives.
Additional retrospective real-world data on the treatment of chronic low back pain in patients with lumbar spondylosis (a degenerative condition affecting the discs, vertebrae, and joints of the spine) is analyzed in the third poster, “Retrospective Review of 60-day PNS Targeting Lumbar Medial Branches in Individuals with Spondylosis Without Radiculopathy.” In this study, 65 percent of patients with suspected and/or confirmed diagnosis of spondylosis (n=173/265) were defined as responders (≥50 percent pain relief and/or clinically significant improvement of ≥1 in Patient Global Impression of Change in function). While safety wasn’t directly evaluated in this analysis, previously published studies have found the most common adverse events to include skin irritation due to bandages or adhesives and discomfort from the lead placement procedure.
“The addition of new functional data and the impressive, steady performance of SPRINT across multiple nerve targets and areas of pain is exciting and validates our belief that this treatment can make an immense impact on pain relief and improvement in quality of life without opioids or the need for permanent implants,” said Maria Bennett, President, CEO and Founder of SPR Therapeutics.
About the SPRINT PNS System
The SPRINT® PNS System, by SPR® Therapeutics, 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, shoulder pain, post-amputation pain, and chronic and acute post-operative 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 post-operative 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 Therapeutics, Inc.
SPR Therapeutics 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.
More information can be found at www.SPRTherapeutics.com.
Contact Data
SPR Contacts:
Michelle McDonald
Vice President – Marketing
844-378-9108
Dave Folkens
Public Relations
612-978-6547
