New SPR therapeutic data presented at ASRA Pain Medicine Meeting 2023
Three posters accepted, including a President’s Choice Award for new data from a randomized controlled trial of postoperative pain in total knee replacement
CLEVELAND, Nov. 13, 2023 (GLOBE NEWSWIRE) — At the 22nd annual American Society of Regional Anesthesia (ASRA) Pain Medicine Meeting in New Orleans, three posters about the SPRINT® PNS system was 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 of a prospective study evaluating the impact of SPRINT peripheral nerve stimulation (PNS) used for chronic knee pain after total knee arthroplasty (TKA). This study not only demonstrated that the majority (60 percent) of the SPRINT PNS treatment group (n=12/20) experienced ≥50 percent pain relief at the 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) showed a 47 percent improvement in walking ability as measured by a six-minute walk test, while the placebo group (n=20) showed a nine percent decrease. This is an important finding for the large number of TKA patients who experience persistent postoperative neuropathic TKA pain (up to 20 percent of the 800,000 patients undergoing TKA surgery annually in the US). There were no study-related serious or unexpected adverse events.
The second poster, “60 Days PNS for Pain Management in a Medicare Eligible Population: Real-World Results 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 more than 6,000 patients. The Medicare eligible population is important because it has been reported that 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 upcoming 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) for all nerve targets . , consistent with recent prospective studies. The total rate of adverse events reported for this Medicare-eligible cohort was four percent, with skin irritation being the most common event, usually 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 intervertebral discs, vertebrae and joints of the spine) are analyzed in the third poster, “Retrospective review of 60-day PNS targeting lumbar medial branches in subjects with spondylosis without radiculopathy.” In this study, 65 percent of patients with a 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). Although safety was not directly evaluated in this analysis, previously published studies have shown that the most common adverse reactions are skin irritation due to dressings or adhesives and discomfort from the lead placement procedure.
“The addition of new functional data and SPRINT’s impressive, stable performance across multiple nerve targets and pain areas is exciting and confirms our belief that this treatment can have a tremendous impact on pain relief and quality of life improvement 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 repair the central nervous system to provide significant and long-lasting relief from chronic pain – without a permanent implant, nerve damage or the risk of addiction. The system has been extensively researched for low back pain, shoulder pain, post-amputation pain and chronic and acute postoperative pain, is approved for use up to 60 days and is recognized by leading pain management centers. Market research shows that this groundbreaking 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, postoperative and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of postoperative pain. The SPRINT PNS System is not intended for placement in the area innervated by the cranial and facial nerves.
Clinicians should use common sense when deciding when to use the SPRINT PNS System. See the SPRINT PNS system instructions for use for more information. The most common side effects are skin irritation and erythema. Results may vary. Rx only.
For additional safety and efficacy information, please visit: SPR Safety Information.
About SPR Therapeutics, Inc.
SPR Therapeutics is a privately held medical device company that offers patients a non-opioid, minimally invasive pain treatment option. Our SPRINT® The PNS System fills a critical unmet need for a drug-free, surgery-free option for millions of people suffering 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 laid an incredibly strong foundation for commercial growth. Headquartered in Cleveland, Ohio with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s senior management team consists of experienced industry veterans with nearly 200 years of collective pain market and MedTech experience, all driven by our goal: improve the quality of patients. ‘ lives by offering them a minimally invasive, drug-free and surgery-free solution to manage their acute and chronic pain.
More information can be found at www.SPRTherapeutics.com.
Contact details
SPR contacts:
Michelle McDonald
Vice President – Marketing
844-378-9108
Dave Folkens
Public relations
612-978-6547
