Empirical Spine initiated the premarket approval process for use of the LimiFlex Paraspinous Tension Band with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial will compare outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression.
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.
The LimiFlex Investigational Device Exemption trial is a two-year 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. 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.
The device received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European patients.
"With trial enrollment fully achieved in 2020, our regulatory effort is now accelerating into the PMAsubmission phase," said 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."