mild(®) Lumbar Decompression for the Treatment of Lumbar Spinal Stenosis

Abstract

More than 1.2 million people are undergoing treatment for lumbar spinal stenosis (LSS) in the United States. Yet, therapeutic options for these patients are limited to either conservative treatments or highly invasive surgeries. A new image-guided interlaminar decompression procedure, mild(®), offers significant relief for many of these patients by debulking dorsal element hypertrophy while preserving structural stability. mild can be performed without general anesthesia and offers a short recovery period. A meta-analysis of four clinical patient series from multiple institutions in the United States evaluated over 250 patients for safety and clinical efficacy of the mild procedure. Clinical efficacy was evaluated at baseline and at three-month follow-up using validated patient reported outcomes (PRO) instruments including the ten-point Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI). Acute safety and patient outcomes was compared to the Spine Patient Outcomes Research Trial (SPORT). No device or procedure-related serious adverse events (SAEs) have been recorded with the mild procedure. Outcome metrics for patients treated with mild demonstrated statistically significant symptomatic improvement over baseline. When compared to open surgery, mild efficacy results compare favorably, and complication rates are much lower. mild is a safe and effective procedure that decompresses LSS in a minimally invasive manner while preserving the structural stability of the spine.