Cleveland, Ohio – March 16, 2023 SPR Therapeutics, a private medical device company focused on treating pain and improving the quality of life for patients suffering from acute or chronic pain, announced the peer-reviewed publication of final patient-reported outcomes from the largest prospective, multicenter trial completed to date of temporary peripheral nerve stimulation (PNS) for chronic low back pain.
Titled “Durable patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial branch nerves,” the study has been published in Interventional Pain Medicine, the official journal of the Spine Intervention Society (SIS) and includes data through the final 14-month follow-up (12 months after the 2-month PNS treatment).
“Some of this study’s most important findings are the continued durability and impacts beyond the 60-day SPRINT® PNS treatment period. These outcomes reinforce our belief that chronic low back pain involves sensitization of neural processes in the central nervous system and further our understanding of how targeted PNS may recondition central sensitization with the potential to provide pain relief that lasts long after the removal of the percutaneous PNS leads,” said Meredith McGee, PhD, Manager of Research and Development at SPR Therapeutics. “Other pain treatments that mask pain without addressing the underlying central sensitization typically require retreatment or permanent peripheral nerve stimulation.”
The primary objective of this prospective multicenter clinical trial was to evaluate the responses of chronic low back pain patients receiving percutaneous PNS of the medial branch nerves. The durability of long-term effects following temporary PNS treatment are characterized in this report. Key findings of the clinical study included:
- The proportion of participants experiencing clinically meaningful improvement in one or more of the outcomes was 77 percent at 14 months. In addition, 58 percent of participants had clinically meaningful improvement in two or more outcomes at 14 months.
- 75 percent of participants who reported taking opioids at baseline reported reductions in opioid consumption in the months after PNS.
- 75 percent of participants said they “agreed” or “strongly agreed” that they would have pursued treatment with SPRINT PNS earlier in their care pathway if it had been available.
- No serious, unanticipated study-related adverse events occurred. The most common adverse events were mild skin irritation or pruritis at the bandage or stimulator’s mounting pad.
“Combined with the results from previous trials, the data now available from this study demonstrate the continued and consistent performance of temporary PNS, suggesting that it warrants consideration earlier in the treatment algorithm for chronic pain patients,” said Christopher Gilmore, MD, of the Carolinas Pain Institute, Investigator on this clinical trial and SPR Consultant. “The non-destructive nature of this approach when compared to ablation is a logical option to consider as, in my experience, most patients prefer the treatment option that offers the least disruption and the SPRINT System does not eliminate the potential for future treatment, if 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 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.
SPR Contacts:
Michelle McDonald
Vice President – Marketing
844.378.9108
Dave Folkens
Public Relations
612.978.6547
SPR Therapeutics Receives 510(k) Clearance of Technological Advancements and an Expanded Intended Patient Population for the SPRINT® PNS System
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