Evidence for long-term, significant relief
Results of the 2023 NOVA randomized clinical trial (RCT)1 demonstrate that Differential Target Multiplexed™ spinal cord stimulation (DTM™ SCS) therapy provides significant, long-term pain relief for patients who have:
- Degenerative disc disease (DDD)
- Herniated disc (HD)
- Radicular pain syndrome (RPS)
The NOVA RCT 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, but had a diagnosis of DDD, HD, or RPS.
DTM™ SCS therapy outcomes
Leg pain relief†
DTM™ SCS provided sustained leg pain relief with a mean VAS score of 1.28 cm at 12 months
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 (0.3 standard error) from baseline
- Sustained leg pain relief with a mean VAS reduction of 6.2 cm (0.4 standard error) 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.
Back pain responder rate†
90.5% — DTM™ SCS back pain responder rate‡ reported at 12 months
(≥50% improvement)
Leg pain responder rate†
90.6% — DTM™ SCS leg pain responder rate reported 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 with the Oswestry Disability Index.
- >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
87.5%
of patients report moderate to minimal disability at 12 months compared to 52% baseline using the ODI.1
Health improvement
89%
of patients felt much improved with DTM™ therapy during their 12-month visit through the Patient Global Impression of Change.1
Therapy satisfaction
93%
of patients felt very satisfied or satisfied with their DTM™ SCS programming at 12 months.1