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![]() This fact alone has helped spur calls for the creation of more flexible systems capable of selectable and multi-programmable outputs that allow for customization of therapy. ![]() While each of these innovations has in part contributed to the advancement of SCS as a therapeutic modality for chronic pain, patients are only typically provided with availability to these newer approaches via separate neuromodulation devices marketed by various device manufacturers. Over the past decade, several new Spinal Cord Stimulation (SCS) approaches have been deployed in the clinical setting, including but not limited to high frequency (1–10 kHz), burst, and high density stimulation in an effort to improve patient outcomes using SCS to treat chronic pain. These results suggest that an implanted SCS device capable of combination therapy, while also enabled with patient-specific waveform optimization and stimulation field targeting capabilities, can enable highly effective pain relief and improve quality of life in patients suffering with chronic pain. Substantial quality-of-life (EQ-5D-5L) improvement as assessed at last follow-up was also observed ( n = 60). Overall pain was reduced by 4.4 ± 2.8 points (NRS) at 3-months ( n = 117) and at 12 months post-implant ( n = 90), respectively ( p < 0.0001). A mean overall pain score of 7.9 ± 1.7 (Standard Deviation (SD)) was reported pre-trial (Baseline). Following implantation, patients were provided with an array of advanced supra-perception programs (e.g., paresthesia-based SCS using multiple independent current sources), and a custom set of sub-perception programs optimized with specific waveforms and/or field shapes. This multicenter, observational case-series evaluated 188 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of sub-perception and supra-perception stimulation programming (i.e., combination therapy) at 16 in Europe. Given the differing mechanisms thought to underlie therapeutic sub- and supra-perception-based neurostimulative modalities, Spinal Cord Stimulation (SCS) systems designed for combined delivery of these approaches may help improve analgesic outcomes and quality of life, and reduce treatment failures.
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