Empirical Spine commenced U.S. market introduction of the LimiFlex Dynamic Sagittal Tether, an outpatient, motion-preserving alternative to spinal fusion following decompression. Broader launch is planned throughout 2026.
The company received FDA Premarket Approval for LimiFlex in early 2026. In the FDA pivotal trial, LimiFlex demonstrated non-inferior 2-year clinical outcomes compared to instrumented spinal fusion. Procedures were substantially shorter than fusion surgery and supported outpatient treatment in indicated patients. LimiFlex patients also demonstrated faster return to work and activities of daily living, improved disability scores, and durable improvements in leg and back pain along with a numerically lower but statistically similar reoperation rate.
“This marks an important milestone for patients with lumbar degenerative spondylolisthesis who have failed conservative treatment,” said Louie Fielding, Co-Founder and President of Empirical Spine, “LimiFlex offers a motion-preserving, outpatient option that allows us to treat many of these patients without defaulting to fusion.”
Empirical Spine commenced U.S. market introduction of the LimiFlex Dynamic Sagittal Tether, an outpatient, motion-preserving alternative to spinal fusion following decompression. Broader launch is planned throughout 2026.
The company received FDA Premarket Approval for LimiFlex in early 2026. In the FDA pivotal trial, LimiFlex demonstrated...
Empirical Spine commenced U.S. market introduction of the LimiFlex Dynamic Sagittal Tether, an outpatient, motion-preserving alternative to spinal fusion following decompression. Broader launch is planned throughout 2026.
The company received FDA Premarket Approval for LimiFlex in early 2026. In the FDA pivotal trial, LimiFlex demonstrated non-inferior 2-year clinical outcomes compared to instrumented spinal fusion. Procedures were substantially shorter than fusion surgery and supported outpatient treatment in indicated patients. LimiFlex patients also demonstrated faster return to work and activities of daily living, improved disability scores, and durable improvements in leg and back pain along with a numerically lower but statistically similar reoperation rate.
“This marks an important milestone for patients with lumbar degenerative spondylolisthesis who have failed conservative treatment,” said Louie Fielding, Co-Founder and President of Empirical Spine, “LimiFlex offers a motion-preserving, outpatient option that allows us to treat many of these patients without defaulting to fusion.”
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