Spinal cord stimulation (SCS) therapy is on-label for treating patients with chronic back pain and a diagnosis of degenerative disc disease (DDD), herniated disc (HD), or radicular pain syndrome (RPS).
Evidence for long-term, significant relief
Results of the 2023 NOVA randomized clinical trial (RCT)1 demonstrate that differential target multiplexed (DTM™) SCS therapy provides significant, long-term pain relief for patients who have:
- DDD
- HD
- RPS
The NOVA study was an on-label, prospective, multicenter, randomized controlled trial that compared Medtronic DTM™ SCS to conventional SCS out to 12 months for patients who were not eligible for spine surgery.
DTM™ SCS therapy outcomes
Leg pain relief†
Sustained leg pain relief with a mean VAS score of 1.28 cm at 12 months with DTM™ SCS
Back pain relief†
DTM™ SCS provided sustained back pain relief with a mean VAS score of 1.46 cm at 12 months
Superior back pain relief compared to
conventional stimulation
Key takeaways for pain relief outcomes
- DTM™ SCS was proven effective at treating chronic back pain patients with DDD, HD, or RPS who are ineligible for spine surgery
- Outcomes at the 12-month follow-up (n=51 subjects for back pain; n=37 subjects for leg pain) included:
- 90.5% back pain responder rate with DTM™ SCS
- 90.6% of leg pain responder rate with DTM™ SCS
- Sustained back pain relief with a mean VAS reduction of 6.4 cm from baseline
- Sustained leg pain relief with a mean VAS reduction of 6.2 cm from baseline
- 90.5% back pain responder rate with DTM™ SCS
- DTM™ SCS provided a 65.5% higher back pain responder rate and 55.8% higher leg pain responder rate than conventional SCS at 12 months (p < 0.0001).
- The primary endpoint was met with DTM™ SCS providing a 57.1% higher back pain responder rate than conventional SCS at 3 months (p <0.0001).
- DTM™ SCS back pain responder rate was 3.6 times higher than conventional SCS at 12 months (p < 0.0001).
Safety outcomes
The incidence of device-related adverse events and serious adverse events were consistent with other SCS studies.
Leg pain responder rate†
90.6% — DTM™ SCS leg pain responder rate reported at 12 months (≥50% improvement)
Back pain responder rate†
90.5% — Back pain responder rate‡ with DTM™ SCS at 12 months (≥50% improvement)
Back pain profound responder rate
(≥80% back pain relief)†
76% - 7 out of 10 patients were profound back pain responders (≥80% relief) with DTM at 12 months.
Leg pain profound responder rate
(≥80% leg pain relief)†
78% - 7 out of 10 patients were profound leg pain responders (≥80% relief) with DTM at 12 months.
Quality-of-life outcomes indicated for chronic back pain patients with DDD, HD, or RPS
- DTM™ SCS provided sustained improvements in the degree of disability and quality of life at a 12-month follow-up.
- >87% of subjects reported minimal to moderate disability with DTM™ SCS at 12 months versus 26.6% at baseline.
- >92% of subjects were satisfied or very satisfied with DTM™ SCS at 12 months.
- >95% of subjects reported being in a better health state with DTM™ SCS at 12 months.
Reduced disability
95%
report moderate to minimal disability at 12 months compared to 52% baseline.1
Improved relief
89%
felt very much or much improved with DTM™ therapy during their 12-month visit.1
Increased satisfaction
93%
of patients felt very satisfied or satisfied with their DTM™ SCS programming at 12 months.1
† mITT analysis = all successfully randomized subjects who completed the trial phase.
‡ Back pain responder rate is defined as a percentage of subjects with a decrease of at least 50% in back pain VAS relative to baseline at 3 months with DTM™ SCS compared to conventional SCS.
1
White T, Justiz R, Almonte W, et al. DTM™ SCS for Indicated Chronic Back Pain Patients Non-Eligible for Spine Surgery: US RCT outcomes. Presented at: North American Neuromodulation Society (NANS) Annual Meeting. Jan. 18-21, 2024. Las Vegas, NV, USA.