The US Food and Drug Administration (FDA) has paved the way for Simpirica Spine to initiate an investigational device exemption (IDE) pivotal clinical study for its LimiFlex spinal stabilisation system.
The LimiFlex stabilisation system is designed to address flexion (forward bending) pain and instability without the need for spinal fusion.
The prospective randomised controlled LimiFlex IDE clinical study is enrolling up to 400 patients to investigate the spinal stabilisation system and instrumented posterolateral fusion following surgical decompression, for the treatment of lumbar degenerative spondylolisthesis with spinal stenosis. The study will evaluate the relative safety and effectiveness of the treatments at the time of surgery and through 24 months post-procedure.
Simpirica Spine president and chief executive officer Austin Noll said the IDE study approval will enable the company to expand the scientific evidence supporting the LimiFlex spinal stabilisation system as a new treatment option for patients with degenerative spondylolisthesis.
"We look forward to beginning the trial and ultimately having the opportunity to make the system commercially available to US surgeons and their patients," Noll added.
The IDE study data will be used to support a premarket approval application to the FDA for the approval of LimiFlex. Simpirica Spine founder Todd Alamin said LimiFlex was designed to improve existing standards of care for patients by providing a minimally invasive and cost effective alternative to fusion. Previous multiple clinical studies have demonstrated considerable reductions in disability and pain, as well as segmental stability at the LimiFlex-stabilised level.
Currently, the device is approved in Europe for use in conjunction with a surgical decompression for the treatment of lumbar spinal stenosis, with or without degenerative spondylolisthesis, but is limited by US law to investigational use only. Simpirica Spine develops minimally invasive, flexion-restricting stabilisation devices for the spine.
Image: Simpirica Spine has gained FDA IDE approval to study the LimiFlex spinal stabilisation system. Photo: FDA.