Background and aims Advancements in spinal cord stimulation (SCS) lead designs, used in combination with neural targeting technologies, are thought to be capable of supporting improved outcomes, including in patients with multi-site and/or evolutive (or changing) pain patterns over time. In this study, SCS outcomes are assessed using a newly available lead with increased span and minimal spacing between electrodes (versus other traditional linear designs).
Methods This is a multicenter, observational clinical study utilizing retrospective chart reviews at selected sites in Europe. We examined a series of chronic pain patients using a 16-contact lead designed for covering up to 3 vertebral levels with a 67 mm active span and 1 mm electrode spacing (Infinion CX, Boston Scientific). All patients were treated per standard of care and implanted with SCS devices using neural targeting algorithms and capable of multiple stimulation waveforms.
Results To date, data analyzed in 15 patients demonstrates a 68% improvement (change in NRS from baseline = 5.7±1.7) in overall pain as reported at last follow up (mean 4.2±5.7 months; p<0.0001). Additionally, a high responder rate (≥50% improvement in overall pain scores) was reported post-trial and at last follow up. 87% of all patients (13 of 15) reported a pain score of 3 or less at last follow-up (baseline mean NRS = 8.3).
Conclusions These early results from this ongoing, multicenter, real-world cohort demonstrate significant improvement in overall pain with the use of recently introduced SCS system with new leads capable of addressing multisite pain and/or changing pain locations.