BACKGROUND AND AIMS
Differential Target MultiplexedTM spinal cord stimulation (also known as DTM™ SCS) is an established therapy that has shown superior back pain relief to traditional SCS.1 Derivatives of DTMTM 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).
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 DTMTM 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). Two tailored specific and validated models utilizing real patient programming data were used for determining recharge interval and device longevity.
Fifty-seven 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.
The use of a DTMTM endurance in this study resulted in clinically meaningful pain relief with reduced energy usage.
This study was funded by Medtronic.