Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band.
In doing so, the FDA has determined that LimiFlex™ holds the potential to offer significant advantages over existing approved or cleared treatment alternatives. Key potential benefits cited in the BDD 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.
“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…