Five things to know:
1. LimiFlex is designed to stabilize the spine as an alternative to spinal fusion and is implanted after a decompression surgery.
2. The trial is studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis.
3. Outcomes will be compared for patients who receive LimiFlex or transforaminal lumbar interbody fusion after decompression surgery.
4. Empirical Spine plans to submit a premarket approval application to the FDA by the end of 2021.
5. LimiFlex has been implanted in more than 2,000 patients in Europe since it received the CE mark in 2009.
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