Empirical Spine Seeks Premarket Approval for Spinal Fusion Alternative
Empirical Spine has filed for FDA premarket approval for its investigational LimiFlex Paraspinous Tension Band.
The device is designed to serve as an alternative to spinal fusion for patients receiving surgical decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis.
The company’s multi-center, controlled clinical trial has met its enrollment goals, exceeding the enrollment of 135 participants into the investigational arm and 160 patients into the control arm.
More than 100 participants have achieved the trial’s primary endpoint, which is measuring the rate of overall clinical success at 24 months, Empirical Spine said.