Empirical Spine has announced completion of enrolment in the investigational arm of its US Investigational Device Exemption (IDE) trial studying the use of the paraspinous tension band 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 has reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial; the control arm will continue enrolling subjects to its target of 160 patients. The results of the LimiFlex trial will form the basis for a premarket approval (PMA) application to the US Food and Drug Administration (FDA).
“As we reach this major milestone, our thanks go out to the fantastic partners who have joined us in the LimiFlex trial,” said Richard Treadwell, CEO of Empirical Spine. “We recognise and appreciate the hard work and dedication of the surgeon investigators and research coordinators, as well as the enthusiasm of the patients in participating in this investigation of a non-fusion alternative for degenerative spondylolisthesis.”
Co-primary investigator Rick Sasso (Indiana Spine Group, Carmel, USA), commented: “My experience with LimiFlex has been very positive. The device may offer a minimally invasive way to stabilise the spine yet preserve motion. Many patients are extremely interested in less invasive stabilisation options that avoid the complications of fusion, so they are attracted to LimiFlex. The device is easy to implant and has demonstrated great results in Europe, which we expect to confirm in this US-based study. We are excited to complete the LimiFlex arm enrolment and over the next 24 months we will be further evaluating the data for submission to the FDA.”
Traditional means of stabilising the spine after decompression surgery involve lengthy, invasive procedures that use bone graft material, combined with instrumentation such as pedicle screws and rods, to fuse two or more vertebrae together. The resulting constructs reduce spinal flexibility and magnify the forces experienced by adjacent levels, often leading to accelerated degeneration of the adjacent spinal segments. While the acute clinical outcomes may be excellent, this accelerated degeneration can lead to longer term issues, sometimes requiring additional surgery.
Occasionally, patients with this instability diagnosis forego stabilization in favor of standalone decompression surgery, which carries a high risk of recurrence and reoperation due to progressive instability.
The LimiFlex was developed as a way of bridging this therapy gap by offering a minimally invasive way to stabilise the spine yet preserve motion. The device aims to restore the spine’s natural biomechanics, along parameters such as stiffness, lordosis, and facet engagement.
The LimiFlex IDE trial is a prospective, multicentre, 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. 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 in over 2,000 European patients.