Vertos Medical Clinical Publication

Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial

Source— Journal of Pain Research Author— Deer T, Kim C, Wahezi SE, Qu H, Sayed D Published June 10, 2021

A prospective randomized controlled trial that evaluates patients treated with the mild® Procedure for lumbar spinal stenosis (LSS) plus conventional medical management (CMM), compared to those treated with CMM alone. Follow-up includes 6-month, 1-year and 2-year assessments, with 1-year being primary. This is a report of interim 6-month outcomes.

CMM involves treatment with one or more conservative or interventional therapies that are commonly used for early treatment of LSS with neurogenic claudication, and may include physical therapy, pain medication, epidural steroid injections (ESIs), nerve blocks, and radiofrequency ablation.

At 6-months, the mild® Procedure combined with CMM provided statistically superior objective real-world outcomes versus CMM-Alone. There were no device- or procedure-related adverse events reported in either study group. With its excellent safety profile and superior efficacy, mild® is uniquely positioned as early first-line therapy.

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