The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device status to Empirical Spine Inc.’s LimiFlex Paraspinous Tension Band.
“Our receipt of the Breakthrough Device Designation is a welcome milestone in realizing our mission to improve the quality of life of patients receiving spine surgery,” said Richard Treadwell, CEO of Empirical Spine. “We appreciated the collaboration with FDA as we identified and addressed the key questions required to secure this designation. We look forward to further collaboration as we gather data supporting our PMA application for US approval. LimiFlex is poised to become a powerful new tool to treat degenerative spondylolisthesis in an effective and less invasive way than the current standard.”
The FDA determined that LimiFlex holds the potential to offer significant advantages over existing approved or cleared treatment alternatives. Key potential benefits cited in the Breakthrough Device Designation application include less invasive and 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.