LimiFlex avoids the use of any screws or bone grafts that disrupt the natural motion between spine segments
Empirical Spine has secured breakthrough device designation (BDD) from the US Food and Drug Administration (FDA) for its LimiFlex paraspinous tension band to treat degenerative spondylolisthesis.
LimiFlex, which is an investigational device, has been developed to serve as an alternative to spinal fusion for patients receiving surgical decompression for grade one lumbar degenerative spondylolisthesis with spinal stenosis.
According to the company, key potential benefits of the device outlined in the BDD application consist of less invasive and shorter surgery, enhanced intra and post-operative outcomes, and reduction or elimination of hospitalisation length of stay.
The benefits also include improved patient quality of life including motion-preservation at the affected spinal level.
LimiFlex avoids the use of any screws or bone grafts that disrupt the natural motion between spine segments.
Empirical Spine has designed the LimiFlex to stabilise the spine without fusing it and preserve motion.
The device is said to work by supporting and enhancing the spine’s natural biomechanics with stabilising yet flexible elements.
The LimiFlex device is designed for placement after a standard decompression surgery within 20 minutes.
Empirical Spine CEO Richard Treadwell said: “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.”
Earlier, the company announced the PMA process with FDA, after fully recruiting a pivotal IDE trial in the last year. The trial involved comparison of LimiFlex to transforaminal lumbar interbody fusion (TLIF) following decompression surgery.
In 2009, the company secured the CE mark approval for the device and has been implanted in more than 2,000 European patients.