CLINICAL OUTCOMES: DTM™ SCS RCT SPINAL CORD STIMULATION

THREE-MONTH OUTCOMES

The DTM™ Spinal Cord Stimulation (SCS) RCT is a prospective, post market, multicenter, randomized control trial comparing the efficacy of DTM™ SCS for back pain compared to conventional SCS.

Three-month outcomes (n=94) were assessed according to the following:

Primary Objective: The effectiveness of DTM™ SCS in reducing back pain as compared to conventional SCS for the treatment of chronic, intractable back pain measured by the percentage of responders (≥50% reduction in pain) at three months post device activation.

Secondary Objectives Included:

  • Comparison of the percentage of individual responders between the test and control groups in a statistical test of superiority
  • Comparison of back pain relief as measured by VAS at three months
  • Frequency of treatment related adverse events

Additional secondary outcomes were also collected and evaluated and will be reported in the future. The frequency, type, seriousness and severity of adverse events, including study-related AEs, demonstrated a risk profile in line with SCS therapy.

NOTE: Subjects will continue to be followed in the Stimgenics DTM™ SCS RCT through 6- and 12-months post-implant. Data presented is from three months follow up.

BACK PAIN RESPONDER RATES (≥ 50% PAIN RELIEF) with superior pain relief with DTM™ SCS AT 3 MONTHS

Graph showing low back pain responder rates at 3 months in DTM vs. conventional SCS. DTM is 80% compared to conventional which is 51%.

DTM™ SCS demonstrated statically significant and superior back pain relief at 3 months (P= 0.0009) when compared to conventional SCS.

BACK PAIN RELIEF BY SUBJECT USING DTM™ SCS compared to CONVENTIONAL SCS AT 3 MONTHS

Graph showing low back pain relief by subject at three months when comparing DTM to conventional SCS. DTM is 80% compared to conventional which is 51%.

63% profound pain relief (≥ 80% reduction in pain) with DTM™ SCS

back pain:  DTM™ SCS COMPARED TO CONVENTIONAL STIMULATION (BASELINE TO 3 MONTHS FOLLOW-UP)

Line graph showing the results of baseline to three-month follow up of DTM compared to conventional SCS for pain relief.

Data shows a 5.4 mean reduction in VAS at 3 months with DTM™ SCS from 7.26 at baseline to 1.88 at 3 months.

PERCENTAGE CHANGE IN BACK PAIN VAS (BASELINE TO 3 MONTHS)

Graph showing the percentage change in low back pain VAS: Baseline to 3 Months. DTM is -74% compared to convention which is -46%.

Data shows a 74% reduction in back pain at 3 months with DTM™ SCS compared with 46% for conventional SCS.

NUMBER OF SUBJECTS BY STUDY VISIT THROUGH 3-MONTH FOLLOW UP

Study Visit Total
N		 DTM
N		 Conventional
N
Implant 94 47 47
3-Month Follow Up 92 46 46