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