Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in the investigational arm of its U.S. IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery. The trial has reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial; the control arm will continue enrolling subjects to its target of 160 patients. The results of the LimiFlex trial will form the basis for a PMA application to the U.S. Food and Drug Administration (FDA).
“As we reach this major milestone, our thanks go out to the fantastic partners who have joined us in the LimiFlex trial,” said Richard…