The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, 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 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.”
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 an 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.
The FDA’s Breakthrough Devices program accelerates the development of medical devices with the potential to effectively treat or diagnose life-threatening or irreversibly debilitating diseases. Currently, an estimated 140,000 patients receive lumbar fusion annually for degenerative spondylolisthesis in the US alone. Despite reported results superior to standalone decompression, instrumented fusion remains an invasive surgical option not appropriate or desirable for many patients due to its longer recovery time and postoperative complications. Post-fusion rates of adjacent segment degeneration, just one important sequela that can lead to additional fusion surgery, range from 20-40% in the literature.
Previously, Empirical Spine announced initiation of the PMA process with FDA, after fully enrolling a pivotal IDE trial in 2020 comparing LimiFlex to transforaminal lumbar interbody fusion (TLIF) following decompression 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, show the potential for LimiFlex to provide a robust, motion-preserving, minimally-invasive, outpatient/ASC solution for this large patient category.
About Empirical Spine
Empirical Spine, Inc. is a privately held company developing advanced solutions for the surgical treatment of spinal disorders. The company is currently running a pivotal IDE trial in the US on its motion-preserving Paraspinous Tension Band, LimiFlex. LimiFlex is a minimally invasive implant that is designed to stabilize the spine after decompression surgery yet preserve motion.
Caution: The LimiFlex Paraspinous Tension Band is an investigational device in the United States and is limited by law to investigational use.
