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EP142 12-month clinical outcomes and energy modeling from a prospective, multi-center study of a differential target multiplexed™ spinal cord stimulation derivative
  1. David Provenzano1,
  2. Kasra Amirdelfan2,
  3. Prahbdeep Grewal3,
  4. Calysta Rice4,
  5. Kate Noel4,
  6. Andrew Cleland4 and
  7. Maddie LaRue4
  1. 1Pain and Interventional Care, Pain Diagnostics and Interventional Care, Sewickley, USA
  2. 2Anesthesiology, IPM Medical Group, Walnut Creek, USA
  3. 3Pain Medicine, TSAOG Orthopaedics and Spine, San Antonio, USA
  4. 4Clinical Research, Medtronic, Fridley, USA


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.

Abstract EP142 Figure 1

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}

Abstract EP142 Table 1

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

  • spinal cord stimulation
  • chronic pain
  • reduced energy
  • patient personlization

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