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
  • 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