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Nicholas Kormylo MD 1 , Tobias Moeller-Bertram MD 1 , Joanne Olecko MS 2 , Kerry Bradley MS 2 ,

Anode Intensity Management (AIM) Improves Selective Stimulation of Dorsal Column (DC) Fibers in SCS. Nicholas Kormylo MD 1 , Tobias Moeller-Bertram MD 1 , Joanne Olecko MS 2 , Kerry Bradley MS 2 , Nitzan Mekel-Bobrov PhD 2 , Dongchul Lee PhD 2 , Jay Schnitzer MD PhD 2

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Nicholas Kormylo MD 1 , Tobias Moeller-Bertram MD 1 , Joanne Olecko MS 2 , Kerry Bradley MS 2 ,

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  1. Anode Intensity Management (AIM)Improves Selective Stimulation of Dorsal Column (DC) Fibers in SCS Nicholas Kormylo MD1, Tobias Moeller-Bertram MD1, Joanne Olecko MS2, Kerry Bradley MS2, Nitzan Mekel-Bobrov PhD2, Dongchul Lee PhD2, Jay Schnitzer MD PhD2 1University of California, San Diego, San Diego, CA 2Boston Scientific Neuromodulation, Valencia, CA

  2. Disclaimer • This study was supported by Boston Scientific Neuromodulation. No disclosures to report.

  3. Fiber diameter (population) 16.0 um (0.005%) 15.0 um (0.01%) 14.0 um (0.025%) 12.8 um (0.08%) 11.5 um (0.25%) 10.0 um (0.5%) 8.7 um (2.5%) 7.3 um (10%) 5.7 um (25%) Background Dorsal Column Morphology • Probability of stimulation proportional to fiber size • Greater than 60% of fibers are < 5.7 um Feirabend, H. K., et al. (2002). Morphometry of human superficial dorsal and dorsolateral column fibres: Significance to spinal cord stimulation. Brain : A Journal of Neurology, 125(Pt 5), 1137-49.

  4. Reversal recruitment order of spinal dorsal column fibers in spinal cord stimulation: Computational model study Dongchul C. Lee*, Kerry Bradley, Michael Moffitt, Dave Peterson Boston Scientific Neuromodulation Threshold vs fiber size dCSF = 3.2 mm 2.6 2.4 2.2 2 Threshold (mA) 1.8 1.6 1.4 1.2 1 0.8 4 6 8 10 12 14 16 Fiber size (um)

  5. Wide Guarded Cathode (WGC) WGC w/ AIM 62.5% 50% 62.5% 50% What is anode intensification?

  6. Clinical Study for AIM Study Design:Prospective, Double-blind, Single-center, Acute Enrollment: • N = 20 (11 M/ 9 F) • Chronic pain patients with low back/leg pain implanted for > 6mo with: • Precision Plus™ SCS IPG • 1 or 2 Linear™ octapolar percutaneous leads positioned between T8-10 (verified by fluoroscopy) Objective:Investigate clinical effect of anode intensification on patient reported paresthesia

  7. AIM Subject 002

  8. AIM Subject 005

  9. AIM Subject 007

  10. AIM Subject 014

  11. Clinical Results Mean deviation from balanced (L = R): 27%( ↓ 8 %) Mean deviation from balanced (L = R): 35%

  12. AIM reduces DR fiber stimulation

  13. Multiple ways to reduce Dorsal Root stimulation

  14. Summary Wide Guarded Cathode WGCw/ AIM • AIM requires independent control of amplitude at cathodes. • AIM reduces dorsal root paresthesia. • AIM can shift stimulation towards physiological midline. • AIM may allow additional dorsal column stimulation unavailable with conventional programming.

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