Nalu Medical has announced the publication of the spinal cord stimulation (SCS) nPower US clinical study in the Pain Physician Journal, reporting on clinical outcomes related to the use of the Nalu SCS system to treat patients suffering from chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
The SCS nPower US clinical study was a prospective, post-market observational study conducted at 15 comprehensive pain centres in the USA. The Nalu neurostimulation system was evaluated in 35 subjects with chronic low back and leg pain from baseline to three months. Highlights of the results include:
- Some 86% of subjects were “responders” (≥50% pain relief) in the low back and leg(s)
- A total of 54% of subjects in the low back and 49% in the leg(s) were “high responders” (≥80% pain relief)
- Roughly 75% average pain reduction in the low back and 76% in the leg(s)
- Nalu’s wearable therapy disc was reported by all patients to be comfortable and easy to use
- Secondary endpoints regarding sleep, mood, functional disability and quality of life all demonstrated statistically significant outcomes at three months compared with baseline
“This study demonstrates best-in-class pain outcomes with the added benefit of a battery-free implant and minimally invasive procedure substantiated by a small, 1.5 cm incision,” said lead author Mehul Desai (International Spine, Pain and Performance Center, Washington DC, USA). “In addition to pain reduction, patients reported holistic improvements that may be attributed to the unique, multi-dimensional waveform that potentially addresses up to six mechanisms of action simultaneously.”
“In addition to strong clinical outcomes, the Nalu SCS system offers interventional pain specialists a treatment option that traditional SCS systems do not provide—a micro-IPG [implantable pulse generator] paired with a wearable battery,” added Nalu chief executive officer Tom West. “The implanted, battery-free micro-IPG is cleared by the FDA [Food and Drug Administration] to last at least 18 years. Therefore, the risks and costs associated with repeated IPG replacement procedures are significantly reduced, while battery replacement surgeries are entirely eliminated. The strong nPower study results in SCS reflect Nalu’s commitment to providing differentiated clinical and health-economic evidence to support the adoption and use of our unique neurostimulation system for chronic intractable pain in both spinal cord stimulation and peripheral nerve stimulation.”
