Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery.
The trial previously exceeded its target of 135 LimiFlex patients enrolled into the investigational arm and 160 patients enrolled into the control arm of the trial.
“With trial enrollment fully achieved in 2020, our regulatory effort is now accelerating into the PMAsubmission phase,” explained Richard Treadwell, Empirical Spine’s CEO. “The FDA’s acceptance of the PMA Shell is an important step towards submitting all three PMA modules,…