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• W4387497653 abstract "<h3>Background and Aims</h3> 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). <h3>Methods</h3> 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. <h3>Results</h3> 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. <h3>Conclusions</h3> 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" @default.
• W4387497653 created "2023-10-11" @default.
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• W4387497653 date "2023-09-01" @default.
• W4387497653 modified "2023-10-12" @default.
• W4387497653 title "EP142 12-month clinical outcomes and energy modeling from a prospective, multi-center study of a differential target multiplexed™ spinal cord stimulation derivative" @default.
• W4387497653 doi "https://doi.org/10.1136/rapm-2023-esra.208" @default.
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