Empirical Spine announced that it completed enrollment in the investigational arm of its U.S. investigative device exemption trial studying its LimiFlex therapy for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis.
The trial reached its target of 135 LimiFlex patients for the investigational arm ,and Empirical Spine plans to continue enrolling the control arm to reach its target of 160 patients. The pivotal trial is slated to compare outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery.
The study’s endpoint is the rate of overall clinical success at 24 months with the goal of displaying that patients can achieve fusion-equivalent results without receiving TLIF treatment, according to a news release. The company said it will use the trial’s results to form the basis for a pre-market approval application to the FDA.
LimiFlex is designed to stabilize the spine and preserve motion while restoring the spine’s natural biomechanics through a minimally invasive procedure. The device won CE Mark approval in 2009 and has been implanted in over 2,000 European patients, according to the release.
“As we reach this major milestone, our thanks go out to the fantastic partners who have joined us in the LimiFlex trial,” Empirical Spine CEO Richard Treadwell said in the release. “We recognize 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.”
“My experience with LimiFlex has been very positive. The device may offer a minimally invasive way to stabilize the spine yet preserve motion,” added Indiana Spine Group president & co-primary investigator Dr. Rick Sasso. “Many patients are extremely interested in less invasive stabilization 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 U.S.-based study. We are excited to complete the LimiFlex arm enrollment and over the next 24 months we will be further evaluating the data for submission to the FDA.”