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FDA approves Simpirica LimiFlex system IDE application

The US Food and Drug Administration (FDA) has approved Simpirica Spin's investigational device exemption (IDE) application to conduct clinical trial of its LimiFlex spinal stabilization system.

The LimiFlex system is designed to treat flexion (forward bending) pain and instability without the need for spinal fusion.

The controlled, prospective, randomized IDE study, enrolling up to 400 patients, will receive either the LimiFlex spinal stabilization system or instrumented posterolateral fusion following surgical decompression for the treatment of lumbar degenerative spondylolisthesis with spinal stenosis.

Investigators will study the safety and effectiveness of the treatments at the time of surgery and through 24 months post-procedure.

The company said results of the study will be used to support a premarket approval (PMA) application to the FDA for approval of the LimiFlex spinal stabilization system.

Simpirica Spine president and chief executive officer Austin Noll said the company looks forward to begin the trial and have the opportunity to make the system commercially available to US surgeons and their patients.