CLEVELAND, March 15, 2022 (GLOBE NEWSWIRE) -- SPR Therapeutics announced publication of a study in the Journal of Pain Research demonstrating how a longer initial treatment period may better identify neurostimulation responders and non-responders in contrast to a conventional, brief (≤10-day) trial period or no trial at all. Permanent systems implanted without a trial or with a short trial have a high failure rate, suggesting that short trials may fail in their intended goal of identifying responders and non-responders. Better understanding of these phenomena could increase access to peripheral nerve stimulation (PNS) for patients with a positive, but delayed response to PNS while reducing the number of costly, permanent implants in patients whose initial positive response wanes rapidly following implantation.
The publication, 60-day PNS Treatment May Improve Identification of Delayed Responders and Delayed Non-responders to Neurostimulation for Pain Relief, evaluated anonymized data from 747 real-world patients who underwent commercial placement of the SPRINT® PNS System leads that are FDA-cleared to remain implanted for up to 60 days. The study found that 38 percent of patients receiving PNS may be mischaracterized if responses to stimulation after a one-week period are considered definitive.
Thirty-one percent of patients initially displayed little pain relief early during the treatment period but eventually became highly responsive to PNS treatment. Over time, these patients achieved 63 percent pain relief on average, which is considered to be highly clinically significant. This improvement throughout the 60 days is consistent with a recently published proposed mechanism of action regarding how the central nervous system may be reconditioned over time.
An additional seven percent of patients, who on average experienced greater than 60 percent pain relief during the first week of treatment, saw a diminishing response over time. For these patients, mean pain relief ultimately dropped below 30 percent, the threshold for clinical significance, by the eighth week of treatment.
Based on the results of this extensive, real-world evaluation there are important considerations for pain physicians:
- A 60-day PNS treatment may help identify delayed responders, highlighting PNS as an effective treatment with the potential for sustained relief without a permanent implant. A shorter stimulation period would have overlooked PNS as a viable treatment option for these patients.
- A 60-day PNS treatment may also help reduce the number of permanent PNS systems implanted by better identifying patients unlikely to respond to PNS in the long term. In addition to the initial implantation costs, many of these patients undergo an additional surgical procedure to have these systems explanted. These are important findings given the cost and invasiveness of permanently implanted neurostimulation systems and the strong patient preference for use of a temporary PNS system prior to considering a permanently implanted system.
“There is tremendous value in the amount of real-world data and experience contained within this study, which can impact how we better approach treatment for patients living with chronic pain,” said lead author Dr. Ramo Naidu, Director of Pain Management at MarinHealth Medical Center. “The SPRINT PNS System’s 60-day treatment may enable more informed clinical decision-making compared to the short trials we have previously been limited to as we work to determine optimized care delivery. A 60-day treatment period provides refined discrimination regarding treatment efficacy, while informing stepwise treatment strategies if follow-on care is needed.”
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 designed 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, and is cleared for use up to 60 days. Recognized by leading pain management centers, the breakthrough neuromodulation treatment offers 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 treat pain in the region innervated by the cranial and facial nerves.
For additional information regarding safety and efficacy, visit www.SprintPNS.com.
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, 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.
