Simpirica Spine has announced that the US Food and Drug Administration (FDA) has approved the initiation of an investigational device exemption pivotal clinical study of its LimiFlex spinal stabilisation system.
The LimiFlex spinal stabilisation system addresses flexion pain and instability without the need for spinal fusion.
The LimiFlex clinical study is a prospective, randomised, controlled study enrolling up to 400 patients at up to 35 US centres. Patients will be randomised at a 2:1 ratio to receive either the LimiFlex spinal stabilisation system or instrumented posterolateral fusion following surgical decompression for the treatment of lumbar degenerative spondylolisthesis with spinal stenosis. Investigators will study the relative safety and effectiveness of the treatments at the time of surgery and through 24 months post-procedure. Results of the study will be used to support a US FDA premarket approval application of the LimiFlex spinal stabilisation system.
“The investigational device exemption study approval is a significant milestone that will allow us to expand the scientific evidence supporting the LimiFlex spinal stabilisation system as a new treatment option for patients with degenerative spondylolisthesis,” said Austin Noll, president and CEO of Simpirica Spine. “We look forward to beginning the trial and ultimately having the opportunity to make the system commercially available to US surgeons and their patients.”
Multiple clinical studies have been conducted on the LimiFlex spinal stabilisation system outside of the United States, with one-year follow-up data demonstrating significant reductions in disability and pain as well as segmental stability at the LimiFlex-stabilised level. The LimiFlex is CE marked and has been available commercially in non-US markets since January 2011.