Largest study of percutaneous peripheral nerve stimulation (PNS) to date advances its consideration as an early neurostimulation treatment option
CLEVELAND, July 12, 2021 – In the largest, most rigorous study to date using the SPRINT® PNS System for chronic axial low back pain (LBP), patients that failed to find relief from at least two different prior LBP treatments (e.g., opioids, over-the-counter analgesics, physical therapy), were treated with the SPRINT PNS System targeting the lumbar medial branch nerves for 60 days.
The multicenter study, recently published in the journal Pain Practice, supports previous research on percutaneous PNS as an effective option in addressing long-term pain without the need for a permanent implant.
The primary endpoint of the study was the percent of participants who experienced a clinically significant reduction in average pain intensity at the end of the 60-day treatment compared to baseline.
- 73 percent of participants experienced a clinically significant reduction in average pain intensity with an average reduction in pain intensity of 58 percent among this group.
- Pain relief was sustained through the last follow-up at 14 months in the majority of those who completed long-term follow-up.
- Participants also reported substantial and statistically significant improvements in secondary endpoints including changes in health-related Quality of Life (QoL), patient global impression of change, and depression.
- 91 percent reported QoL improvements with 59 percent defining their quality of life as “Much Improved” or “Very Much Improved.”
“This study represents a significant step in the ongoing evolution of the SPRINT PNS System as a first-line neurostimulation treatment for patients and as an important solution for those who have tried and failed to find relief using other approaches for their low back pain,” said Christopher Gilmore, MD, of the Carolinas Pain Institute who was lead author of the study. “This multicenter study included a range of participating physicians and clinical care settings including large academic institutions and private practices, in urban as well as rural locations. Seeing positive generalized outcomes across diverse patient profiles is encouraging and rewarding as we strive to provide relief for a huge patient population struggling with low back pain seeking an effective and minimally-invasive solution.”
About the SPRINT® PNS System
The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, restorative, 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.
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.
The SPRINT PNS System is indicated for up to 60 days in the back and/or extremities for: (i) Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; (ii) Symptomatic relief of post-traumatic pain; and (iii) Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the craniofacial region.
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.
Important safety & risk information: https://bit.ly/2FU92NH