Ashwini Sharan, MD¹, Vahid Mohabbati, MD², Richard Sullivan, MBChB³, James Yu, MD⁴,  Peter Georgius, MBBS⁵, Charles D Brooker, MBChB⁶, Malgorzata Straka, PhD¹, Andrew J Cleland, MD¹, Glenn Butler¹, Michelle Knight, BSc¹, Zachary Kyle-Little, BSc¹, Justin Morey¹, Nancy L McClelland, BSN¹, Charles Cain, PhD¹, Abi Franke, PhD¹, Marc A Russo, MBBS⁷

¹Medtronic, Minnesota, USA, ²Sydney Pain Research Centre, New South Wales, Australia, ³Precision Brain Spine and Pain Center, Victoria, Australia, ⁴Australian Medical Research, New South Wales, Australia, ⁵Sunshine Coast Clinical Research, Queensland, Australia, ⁶Royal North Shore Hospital, New South Wales, Australia, ⁷Genesis Research Services, New South Wales, Australia 

• Closed-Loop SCS (CL-SCS) system adjusts amplitude, to account for changes in lead to cord distance, based on the measured physiologic response of the spinal cord – the evoked compound action potential (ECAP).¹ 

• CL-SCS aids in consistent delivery of dose to achieve analgesia. Here we report outcomes with CL-SCS with a variety of waveforms tailored to the patient’s needs. 

• Prospective, trial being conducted at 7 sites in Australia with study visits at  1-, 3-, 6-, 12-, 18-, and 24-months post device activation. Subjects with a successful SCS trial  (≥50% reduction) were implanted with the study device. Each subject could have up to 4 optimization visits prior to the 1-month visit. (NCT05177354) 

• Primary objective is to demonstrate reduction in overstimulation with the CL feature during randomized, single blind testing with an open-loop SCS control arm at 1-month. The primary analysis set (PAS) includes the first 28 back/leg pain subjects to complete the 1-month visit; stimulation     amplitude was  programmed at/above perception for this testing.

• Secondary objective is to characterize % of subjects with ≥50% reduction in overall, back/leg pain at 3 months; there is no control arm for this testing.

• Data from 26 of the 28 subjects in the PAS that completed the 3-month visit are presented here; 2/28 did not complete the 3-month visit  – 1 missed visit and 1 due to an adverse event.

Primary Endpoint: Closed-Loop Reduced Overstimulation in 89% of PAS Subjects (at 1-month)

Substantial reductions in Overall Back/Leg Pain was Observed at 3 months with Tailored Waveforms further Optimized with the CL feature

Health-Related QoL Improved Significantly (per EQ-5D), 81% (21/26) reported better Health State*

% with Severe disability or Worse reduced from 85% to 23%

 

• Patient Reported Outcomes are comparable to previous studies with CL-SCS and other modern waveforms.2, 4-6

• 89% were a great deal better/better (per PGIC) and 100% reported being very satisfied/satisfied with the therapy (n = 26).