Sam Brusco, Associate Editor01.19.24
Medtronic has revealed data from two clinical trials for its closed-loop, Differential Target Multiplex (DTM) spinal cord stimulation (SCS) technologies for chronic low back pain (CLBP) and leg pain patients. The data was presented as late-breaking presentations at this year’s North American Neuromodulation Society (NANS) annual meeting.
The secondary objective was also met, with 86% of subjects reporting 50% or more back and leg pain reduction at three months. Over 80% could achieve stated activity goals for daily living with SCS therapy. And though the study didn’t have a weaning protocol, 35% of subjects on opioids at baseline reduced or stopped use at three months.
Superior back pain responder rate for DTM SCS was shown with CLBP at 12, 18, and 24 months. At 24 months, 77% reduction in CLBP was reported for subjects using DTM SCS, with 93% leg pain responder rate as well.
There was also reduction in the extent of disability with DTM SCS, and 95% of patients reported being satisfied or very satisfied with the treatment.
“Insights gained today from new clinical evidence pave the way toward the revolutionary therapies of tomorrow, and Medtronic is proud to be leading the way at NANS 2024 with 26 accepted clinical abstracts,” said Paolo Di Vincenzo, president of Medtronic’s Neuromodulation business. “We are committed to advancing the field of neuromodulation through rigorous scientific research in order to deliver on our Mission to alleviate pain, restore health and extend life to patients around the world.”
Medtronic also highlighted its recently U.S. Food and Drug Administration (FDA) approved Percept RC neurostimulator with BrainSense technology at the NANS meeting.
One and Three-Month Outcomes from Australia Closed Loop-SCS Study
The primary objective was met with 89% of subjects reporting “significant reduction” in overstimulation relative to open-loop. 86% reported a preference for closed-loop during blinded testing at one month. Improvements were shown for pain, physical function, and quality of life at three months for closed-loop SCS.The secondary objective was also met, with 86% of subjects reporting 50% or more back and leg pain reduction at three months. Over 80% could achieve stated activity goals for daily living with SCS therapy. And though the study didn’t have a weaning protocol, 35% of subjects on opioids at baseline reduced or stopped use at three months.
24-Month European RCT Data Comparing DTM SCS to Conventional Medical Management (CMM)
The post-market, on-label study is the first EU-based RCT to show long-term benefits of DTM SCS for indicated CLBP patients who aren’t eligible for spinal surgery. The trial was conducted at 12 sites in four European countries.Superior back pain responder rate for DTM SCS was shown with CLBP at 12, 18, and 24 months. At 24 months, 77% reduction in CLBP was reported for subjects using DTM SCS, with 93% leg pain responder rate as well.
There was also reduction in the extent of disability with DTM SCS, and 95% of patients reported being satisfied or very satisfied with the treatment.
“Insights gained today from new clinical evidence pave the way toward the revolutionary therapies of tomorrow, and Medtronic is proud to be leading the way at NANS 2024 with 26 accepted clinical abstracts,” said Paolo Di Vincenzo, president of Medtronic’s Neuromodulation business. “We are committed to advancing the field of neuromodulation through rigorous scientific research in order to deliver on our Mission to alleviate pain, restore health and extend life to patients around the world.”
Medtronic also highlighted its recently U.S. Food and Drug Administration (FDA) approved Percept RC neurostimulator with BrainSense technology at the NANS meeting.