Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, announced the initiation of the PMA process for FDA review and approval of the use of the LimiFlex with 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.
Richard Treadwell, CEO, Empirical Spine, said: “With trial enrollment fully achieved in 2020, our regulatory effort is now accelerating into the PMAsubmission phase. The FDA’s acceptance of the PMA Shell is an important step towards submitting all three PMA modules, which we expect to accomplish by the end of 2021.”
Rick Sasso, Co-principal Investigator, MD, Indiana Spine Group, commented: “My experience with LimiFlex has been very positive. The device may offer a minimally invasive way to stabilize the spine yet preserve motion. LimiFlex also represents a new alternative as an outpatient procedure, with 2/3 of LimiFlex patients discharged the same day and almost half treated in ASC settings.”
William Welch, MD, University of Pennsylvania and Co-Principal Investigator of the LimiFlexIDE study, added: “I am encouraged by the clinical outcomes and results we have seen so far in the study. LimiFlex is an exciting new possibility for patients currently undergoing fusion for degenerative spondylolisthesis and would offer much faster recovery for patients, significant savings for payors, and more surgical offerings for spine surgeons.”