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# Empirical Spine Breakthrough for Spinal Tension Band
- URL: https://www.fdaweb.com/empirical-spine-breakthrough-for-spinal-tension-band/
- Published: 2021-04-02T12:00:00.000Z
- Updated: 2026-09-14T16:53:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149034

FDA has granted Empirical Spine a breakthrough device designation for its LimiFlex Paraspinous Tension Band and its use in spinal surgery. Key potential benefits cited in the company’s breakthrough request include “shorter surgery, improved intra- and post-operative outcomes, reduction or elimination of hospitalization length of stay, and improved patient quality of life, including motion-preservation at the affected spinal level.”  

LimiFlex is an investigational device designed as an alternative to spinal fusion for patients receiving surgical decompression for Grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. It does not involve any screws or bone grafts, which disrupt the natural motion between spine segments, the company says. Instead, the device is designed to stabilize the spine without fusing it, thereby preserving motion. According to Empirical, the device is placed following a standard decompression surgery, typically in less than 20 minutes. with stabilizing yet flexible elements.