Empirical Spine has recently achieved a number of clinical, reimbursement and regulatory milestones in the past 12 months that have helped move its LimiFlex Dynamic Sagittal Tether (DST) closer to market in the US.
LimiFlex is an investigational device targeting grade one lumbar degenerative spondylolisthesis patients with spinal stenosis, and is designed to restore natural segmental motion and stability after an open lumbar decompression by augmenting the posterior tension band. The DST is intended to be an alternative to spinal fusion.
Last year the US Food and Drug Administration (FDA) granted LimiFlex breakthrough device designation. LimiFlex’s three-part Modular PMA process with the FDA has commenced, with Module 1 already having been submitted and feedback received. The remaining modules are being completed and will be submitted in the coming months, say Empirical Spine.
Additionally, in November last year outcomes from the LimiFlex investigational device exemption study were presented at the Society for Minimally Invasive Spine Surgery Annual Forum by study investigator Hyun Bae (Los Angeles, USA).
The study included 246 subjects with 12-month follow-up. According to a company press release, Bae presented study conclusions showing the investigational LimiFlex group demonstrated similar improvement in disability yet nine weeks’ faster mean time to return to work (when applicable) and activities of daily living compared to the control transforaminal lumbar interbody fusion group.
Richard Treadwell, president and CEO of Empirical Spine, said: “The milestones we achieved last year are advancing Empirical Spine’s mission to improve the quality of life of patients receiving spine surgery with our first-in-class DST. LimiFlex has the potential to change the spinal surgery standard for the many patients who fall within our indication by enhancing the natural function of the body.
“Moreover, LimiFlex offers the potential for significant cost savings compared to inpatient fusion surgery. I expect 2022 to be an exciting year for the company as we leverage the progress we made in 2021 and enter the final run up leading to market.”
LimiFlex received the CE mark in 2009 and has been implanted in more than 2,000 European patients.