The FDA granted Empirical Spine’s LimiFlex dynamic saggittal tether premarket approval.
LimiFlex is a motion-preserving system for lumbar spinal stenosis associated with Grade I degenerative spondylolisthesis after decompression, according to a Feb. 18 news release. The system was developed from foundational research at Stanford (Calif.) University.
The system stabilizes the spine following decompression without rigid fixation. In an FDA trial Limiflex showed non-inferior two-year clinical outcomes compared with instrumented spinal fusion. Procedures were also shorter than fusions and supported outpatient care.
A limited launch of LimiFlex is expected to begin at select medical centers that participated in the FDA’s IDE trial.
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