Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in its U.S. IDE trial studying the use of 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 reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial in December 2019 and the control arm has achieved its target of 160 patients. To date, a total of 168 study subjects have reached 12 months follow up. The results of the LimiFlex trial will form the basis for a PMA application to the U.S. Food and Drug Administration (FDA), anticipated by the end of 2021.
“As we reach this major milestone, our thanks go out to the…