2 results
Approved WMOCompleted
This clinical trial will test the safety and performance of the Spinal Modulation Neurostimulator System in the treatment of chronic pain.Outcomes:Primary Outcomes: 1) Safety as determined by adverse event reporting2) Device performance as…
Approved WMOCompleted
The primary safety endpoint is to evaluate a 30-day major adverse event (MAE) rate, where MAE is a composite of the following device- or procedure-related events: * All-cause mortality* Stroke* Life-threatening bleeding (MVARC scale)* Major vascular…