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Abstract
Background and Aims Differential Target Multiplexed™ spinal cord stimulation (DTM™ SCS) is an established therapy that has shown superior back pain relief to traditional SCS [1]. Derivatives of DTM™ are being investigated to understand opportunities for therapy personalization. This prospective, multi-center, open- label, post-market study evaluated the efficacy and energy use of reduced-energy DTMTM derivative (DTM™ endurance).
Methods SCS candidates with an overall Visual Analog Score (VAS) of ≥6 with moderate to severe chronic, intractable back and/or leg pain were eligible. Eligible subjects underwent an SCS trial programmed with DTM™ endurance and proceeded in study if successful. Evaluation visits occurred at 1-, 3-, 6-, and 12-months post-activation. Programming data was used to calculate battery energy usage (Intellis™, Medtronic). 2 tailored specific and validated models utilizing real patient programming data were used for determining recharge interval and device longevity.
Results 57 subjects enrolled at 12 US sites from November 2020 – June 2021 (demographics in table 1). Post-laminectomy pain/PSPS was the main etiology (91.2%). 49 subjects underwent trial, 35 were implanted, and 27 completed the 12-Month visit. Changes in overall, back, and leg pain were clinically sustained through 12-months (figure 1). Outcomes including quality of life, disability, and safety will be presented. Therapy energy usage was consistent throughout the duration of the study, with a mean current usage of 55 µC/s at 12-months. Amplitude ranges, cycling parameters, recharge interval and duration, and longevity will be reported.
Visual analog sea le (VAS} scores for overall, back and leg pain. Values shown represent mean VAS scores (scale of 0 ta 10, with 10 being the most pain} tram per-protocol subjects at baseline, 3-month, 6-month and 12-month follow-up. Error bars represent Standard Error (SE}
Baseline demographics for enrolled and implanted subjects
Conclusions The use of a DTM™ endurance in this study resulted in clinically meaningful pain relief with reduced energy usage.
IRB Approval – Initial IRB Approval – Initial