Nalu Medical has announced the publication of real-world data in the journal Chronic Pain and Management, describing this as a “significant milestone” that establishes Nalu peripheral nerve stimulation (PNS) as a medically necessary treatment for chronic pain.
This analysis includes data from 2,273 patients implanted with the Nalu micro-implantable pulse generator (IPG) PNS system, making it the largest published real-world dataset on a permanent PNS device to date, according to the company. The large sample size and a responder rate of 94%—as measured by patient global impression of change (PGIC)—constitute “solid evidence of reliable, exceptional effectiveness”, Nalu claims.
“The consistent improvements observed across a large, diverse sample of real-world clinic patients treated in multiple anatomic regions and nerve combinations emphasises the broad applicability of PNS therapy delivered by the Nalu micro-IPG PNS system,” said John Hatheway (Franciscan Pain Management Clinic at St Anthony, Gig Harbor, USA), lead author of the paper.
These real-world data are claimed by Nalu to confirm the published one-year findings of the COMFORT randomised controlled trial (RCT), with the magnitude of the present sample size now supporting generalisation of those findings to the population at large. Combined with published data reporting a 50% reduction in total healthcare costs among patients receiving Nalu PNS therapy, these findings provide strong real-world evidence supporting expanded coverage of PNS by private insurers, as noted in a recent press release from the company.
“These real-world results provide unmistakable evidence that the Nalu micro-IPG PNS system is dramatically reshaping pain management,” added Tom West, president and chief executive officer (CEO) of Nalu. “No permanent PNS system has undergone greater scrutiny or shown comparable performance. We are thrilled to see that our groundbreaking technology is able to provide reliable long-term pain relief to such a broad spectrum of patients.”
