CLEVELAND, March 16, 2023 (GLOBE NEWSWIRE) — SPR Therapeutics, a non-public medical gadget firm targeted on treating ache and bettering the standard of life for sufferers affected by acute or persistent ache, introduced the peer-reviewed publication of ultimate patient-reported outcomes from the most important potential, multicenter trial accomplished to this point of momentary peripheral nerve stimulation (PNS) for persistent low again ache.
Titled “Sturdy patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial department nerves,” the research has been revealed in Interventional Ache Drugs, the official journal of the Backbone Intervention Society (SIS) and consists of knowledge by the ultimate 14-month follow-up (12 months after the two-month PNS therapy).
“A few of this research’s most vital findings are the continued sturdiness and impacts past the 60-day SPRINT® PNS therapy interval. These outcomes reinforce our perception that persistent low again ache includes sensitization of neural processes within the central nervous system and additional our understanding of how focused PNS could recondition central sensitization with the potential to supply ache aid that lasts lengthy after the elimination of the percutaneous PNS leads,” mentioned Meredith McGee, PhD, Supervisor of Analysis and Growth at SPR Therapeutics. “Different ache therapies that masks ache with out addressing the underlying central sensitization usually require retreatment or everlasting peripheral nerve stimulation.”
The first goal of this potential multicenter medical trial was to guage the responses of persistent low again ache sufferers receiving percutaneous PNS of the medial department nerves. The sturdiness of long-term results following momentary PNS therapy are characterised on this report. Key findings of the medical research included:
- The proportion of individuals experiencing clinically significant enchancment in a number of of the outcomes was 77 p.c at 14 months. As well as, 58 p.c of individuals had clinically significant enchancment in two or extra outcomes at 14 months.
- 75 p.c of individuals who reported taking opioids at baseline reported reductions in opioid consumption within the months after PNS.
- 75 p.c of individuals mentioned they “agreed” or “strongly agreed” that they’d have pursued therapy with SPRINT PNS earlier of their care pathway if it had been out there.
- No critical, unanticipated study-related hostile occasions occurred. The most typical hostile occasions had been gentle pores and skin irritation or pruritis on the bandage or stimulator’s mounting pad.
“Mixed with the outcomes from earlier trials, the info now out there from this research display the continued and constant efficiency of momentary PNS, suggesting that it warrants consideration earlier within the therapy algorithm for persistent ache sufferers,” mentioned Christopher Gilmore, MD, of the Carolinas Ache Institute, Investigator on this medical trial and SPR Advisor. “The non-destructive nature of this strategy when in comparison with ablation is a logical choice to think about as, in my expertise, most sufferers favor the therapy choice that provides the least disruption and the SPRINT System doesn’t eradicate the potential for future therapy, if wanted.”
Concerning the SPRINT PNS System
The SPRINT® PNS System, by SPR® Therapeutics, marks an progressive shift within the therapy of ache. Our breakthrough, 60-day therapy is a First-Line™ PNS choice uniquely proposed to recondition the central nervous system to present important and sustained aid from persistent ache — with out a everlasting implant, nerve destruction or the danger of dependancy. The system has been studied extensively for low again ache, shoulder ache, post-amputation ache, and persistent and acute post-operative ache, is cleared to be used as much as 60 days, and is acknowledged by main ache administration facilities. Market analysis signifies that this breakthrough neuromodulation therapy is a patient-preferred various to extra invasive choices.
The SPRINT PNS System is indicated for as much as 60 days for: Symptomatic aid of persistent, intractable ache, post-surgical and post-traumatic acute ache; symptomatic aid of post-traumatic ache; symptomatic aid of post-operative ache. The SPRINT PNS System just isn’t meant to be positioned within the area innervated by the cranial and facial nerves.
Physicians ought to use their finest judgment when deciding when to make use of the SPRINT PNS System. For extra data see the SPRINT PNS System IFU. Most typical hostile occasions are pores and skin irritation and erythema. Outcomes could differ. Rx solely.
For added data relating to security and efficacy, go to: SPR Security Info.
About SPR Therapeutics, Inc.
SPR Therapeutics is a privately held medical gadget firm, offering sufferers with a non-opioid, minimally invasive ache therapy choice. Our SPRINT® PNS System fulfills a essential unmet want for a drug-free, surgery-free choice for hundreds of thousands who are suffering from persistent ache. Backed by the most important physique of medical proof in peripheral nerve stimulation for the therapy of ache, SPR has demonstrated business demand in untapped peripheral (shoulder and knee) and again ache markets and constructed an extremely robust basis for business progress. Headquartered in Cleveland, OH with satellite tv for pc workplaces in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Administration crew consists of skilled trade veterans with almost 200 years of collective ache market and MedTech experience, all pushed by our goal – to enhance the standard of sufferers’ lives by offering them with a minimally-invasive, drug-free, surgery-free answer to handle their acute and persistent ache.
Extra data may be discovered at www.SPRTherapeutics.com.
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