CLINICAL OUTCOMES: DTM™ SCS RCT SPINAL CORD STIMULATION

LONG-TERM AND SUSTAINED OUTCOMES1

The DTM™ Spinal Cord Stimulation (SCS) RCT1 is a prospective, post-market, multicentre, randomised control trial comparing the efficacy of DTM™ SCS for back pain compared to conventional SCS. Both therapies were evaluated using the Intellis™ neurostimulator.

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 evaluated through 12 months:

  • Comparison of the percentage of individual responders between the test and control groups in a statistical test of superiority
  • Comparison of back and leg pain relief as measured by VAS
  • 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: Data presented is from twelve months follow up.

pdf DTM™ SCS RCT (.pdf)

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Download the Study results here
DTM™ SCS RCT Study

STUDY OUTCOMES1

back pain graph

84%

Highest back pain responder rate

reported at 12 months in similar RCTs*

(> 50% improvement).

* Descriptive comparison, including studies with similar design (RCT; randomisation >100 subjects; comparing 2 SCS therapies; with at least 12-months follow up) and patient populations (inclusion/exclusion criteria; baseline demographics) with back pain responder rates reported. This is not based on a statistical analysis of outcomes between studies.

BACK PAIN RELIEF BY SUBJECT USING DTM™ SCS compared to CONVENTIONAL SCS AT 12 MONTHS

back pain gifs

69% profound pain relief (≥ 80% reduction in pain) with DTM™ SCS

back pain:  DTM™ SCS COMPARED TO CONVENTIONAL STIMULATION
BASELINE TO 12 MONTHS FOLLOW-UP

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PRODUCT PERFORMANCE

DATA

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See prospective, long-term multicentre registry study data for spinal cord stimulation systems.

VIEW DATA
1

Fishman M, Cordner H, et al. DTM™ SCS RCT 12-month data results. Presented at a Medtronic webinar, jointly supported by the North American Neuromodulation Society (NANS), World Institute of Pain (WIP), and the American Society for Pain and Neuroscience (ASPN). October 19, 2020. Webinar available on society websites.

See the device/therapy manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events, If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.