That’s one of the initial takeaways from study results that medical device companies in the neuromodulation space are touting this weekend at NANS 2020 in Las Vegas. NANS is a joint conference of Congress of Neurological Surgeons and the North American Neuromodulation Society.
We’ll keep you updated with news as it comes out. Read on and discover what we have so far.
1. Medtronic touts back pain-relief study results
The medtech giant reported “statistically significant and superior back pain relief” from a study of the differential targeted multiplexed (DTM) spinal cord stimulation (SCS) tech it acquired through its recent purchase of Stimgenics.
The multicenter, randomized controlled trial pits DTM against traditional SCS in 94 patients. Three-month results showed 80% of patients with chronic back pain reported at least 50% pain relief with DTM treatment, compared with 51% of patients treated with conventional SCS, as measured by the Visual Analog Scale (VAS). The trial also demonstrated “profound pain relief” of 80% or greater in nearly two-thirds of patients treated with DTM compared with 26% who had conventional treatment, the company said.
Both arms used the Medtronic Intellis platform. The study will continue to follow patients through 12 months post implant.
“DTM therapy is the first tailored SCS approach intentionally developed from a novel scientific concept and demonstrated in an RCT,” said Matt Thomas, VP and GM of Medtronic’s stim and early interventions business. “The study demonstrates that DTM therapy provides superior efficacy for patients with chronic back pain compared to conventional stimulation.”
2. Abbott reports studies of pain-related mental health and physical activity
Abbott reported positive results from a prospective, multi-center study of 24 patients who used its Proclaim XR neurostimulation system for chronic pain.
Proclaim XR is a low-dose, recharge-free spinal cord stimulation implant with up to 10-year battery life. Its BurstDR stimulation waveform was designed to mimic natural patterns found in the brain and to use low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain.
Data from the 24-patient study found that BurstDR reduced pain-catastrophizing scale scores (PCS) by an average of 62%. PCS is a patient-reported measure used to determine how pain affects the mental state of a person experiencing chronic pain.
The BOLD study showed that 78% of patients had a baseline Oswestry Disability Index (ODI) score of “severe,” “crippling” or “bed-bound.” After six months of treatment with Proclaim XR, 71% reported a minimal or moderate ODI score and the rest noting having a “severe” or “crippling” ODI score. ODI is a disease-specific measurement that is used to determine the patient’s physical level of disability and measure change over a period of time.
“We’re still only scratching the surface of what spinal cord stimulation can do in patients experiencing chronic pain,” added Keith Boettiger, VP of Abbott’s neuromodulation business. “The more we learn and study the BurstDR stimulation waveform and low intermittent dose stimulation, the more we are able to apply this technology to real world-situations.”
Data from the 269-patient international TRIUMPH study, also presented at NANS, showed significant improvements in physical, mental and emotional function were sustained for up to one-year, post-permanent implant, Abbott said. Patients also reported a reduction in the impact of pain on daily life, which resulted in patients becoming more active when measured at one year.
“These collective data illustrate the important and promising physical and mental health benefits of the BurstDR stimulation waveform for people living with chronic pain,” said Dr. Steven Falowski, director of Functional Neurosurgery at Neurosurgical Associates of Lancaster in Pennsylvania, in a news release. “We now have clinical evidence that Proclaim XR, using the BOLD dosing protocol, shows reductions in two standard measures of characterizing pain. The improvements in these two areas are critical factors in creating personalized care plans that help individuals feel better overall and treating the multiple aspects of pain.”
3. SPR Therapeutics touts low-back-pain study results
SPR Therapeutics said its Sprint peripheral nerve stimulation (PNS) system demonstrated a 63% reduction in average pain intensity at one year following treatment.
The Sprint PNS system is the only PNS system that doesn’t require permanent implantation, according to the company. The study followed in nine patients who used it for 60 days and was published in Pain Practice.
“The results reported in this latest study of the Sprint PNS system showing sustained relief of chronic LBP and disability for at least 12 months in the majority of patients highlight the potential for percutaneous PNS to obviate the need for opioids and more invasive procedures,” said lead author Dr. Christopher Gilmore of the Carolinas Pain Institute in a news release. “This is consistent with previously published research assessing percutaneous PNS for other pain syndromes, where clinically significant reductions in pain and improvements in pain‐related disability were also sustained long‐term. This approach has the potential to significantly influence the care continuum for chronic back pain patients by providing a minimally-invasive and short-term neurostimulation treatment to patients earlier than has been previously possible.”