Nalu SCS System Shows 75% Pain Reduction in U.S. Study

Nalu Medical has announced publication of its SCS (spinal cord stimulation) nPower U.S. clinical study in Pain Physician Journal.
 
The report describes clinical outcomes related to use of the Nalu SCS system to treat chronic, intractable pain of the trunk and/or limbs, both unilateral and bilateral. The prospective, post-market observational study was conducted at 15 comprehensive U.S. pain centers, in 35 patient with chronic low back and leg pain from baseline to three months.
 
86% of subjects were “responders” (≥50% pain relief) in the low back and leg(s). 54% of subjects in the low back and 49% in the leg(s) were “high responders” (≥80% pain relief).
75% average pain reduction was found in the low back and 76% in the leg(s). The 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 3 months compared with baseline.
 
According to lead author, Dr. Mehul Desai, “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. In addition to pain reduction, patients reported holistic improvements that may be attributed to the unique multi-dimensional waveform that potentially addresses up to 6 mechanisms of action simultaneously.”
 
Tom West, Nalu CEO, added, “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 paired with a wearable battery. The implanted, battery-free micro-IPG is cleared by the FDA 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.”