ID: 203617 One-Year Safety Analysis Using DRG-Stimulation for the Treatment of Lower Limbs CRPS I and II

Dorsal root ganglion stimulation (DRG-S) is effective for the treatment of chronic focal pain conditions1 and superior to traditional spinal cord stimulation (SCS) in the treatment of CRPS types I and II (causalgia).2,3 To provide continued evidence of safety after FDA approval, a post-market, prospective, single-arm, observational study in patients with CRPS types I or II of the lower limbs treated with DRG-S was designed (NCT02800863). The primary goal of the study was to show that the proportion of serious adverse effects (SAEs) in subjects who received a permanent implant was lower than a pre-specified goal of 15.5% after 12 months. SAEs were defined as safety-related device and non-device events that result in the subject's death or a serious deterioration in health that is life-threatening, results in permanent impairment, or requires medical intervention and hospitalization. The study descriptive endpoint was the proportion of subjects with device, procedure, or stimulation-related SAEs (SADE) or AE (ADE)