Empirical Spine Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, FDA has granted Breakthrough Device Designation (BDD) for its LimiFlex Paraspinous Tension Band.
FDA concluded 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.
Richard Treadwell, CEO, Empirical Spine, said: “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. 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.”
LimiFlex, new to the US market, 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. LimiFlex does not involve any screws or bone grafts, which disrupt the natural motion between spine segments. Instead, LimiFlex is designed to stabilize the spine without fusing it, thereby preserving motion. The device works by supporting and enhancing the spine’s natural biomechanics with stabilizing yet flexible elements.
The LimiFlex device is placed following a standard decompression surgery, typically in less than 20 minutes. The less invasive nature of the procedure also offers promise as outpatient or ambulatory surgery, providing significant flexibility to patients and their surgeons, as well as the potential for significant cost savings compared to inpatient fusion surgery.
LimiFlex received the CE mark in 2009 and has been implanted with excellent results in over 2,000 European patients. Results to date, including 10-years’ experience with the device in Europe, showing the potential for LimiFlex to provide a robust, motion-preserving, minimally-invasive, outpatient/ASC solution for this large patient category.