Empirical Spine, maker of the LimiFlex paraspinous tension band, has announced initiation of the PMA process for the US Food and Drug Administration (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.
According to Empirical Spine, 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, which we expect to accomplish by the end of 2021.”
Co-principal investigator Rick Sasso, of the Indiana Spine Group commented, “My experience with LimiFlex has been very positive. The device may offer a minimally invasive way to stabilise 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, 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.”
Empirical Spine reported the LimiFlex IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the LimiFlex Paraspinous Tension Band compared to TLIF in patients suffering from degenerative spondylolisthesis and lumbar spinal stenosis. The study endpoint is the rate of overall clinical success at 24 months. Currently, over 200 patients have reached 12 months follow-up and more than 100 patients have achieved the 24-month primary endpoint. The goal is to show that patients can achieve fusion-equivalent results – without the fusion.