Empirical Spine has revealed that it has recently completed the final step in the US Food and Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST).
The Premarket Approval (PMA) submission included Module III, with data and analysis of the two-year results from the pivotal investigational device exemption (IDE) clinical trial comparing LimiFlex DST stabilisation versus fusion surgery for degenerative spondylolisthesis patients with spinal stenosis.
According to the company, the LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical option for this specific patient population. The device previously received the FDA’s breakthrough designation for its potential to provide significant advantages over currently approved spinal stabilisation technologies.
The LimiFlex DST uses a completely different concept than past devices to provide durable symptom resolution while preserving spinal motion, say Empirical Spine. LimiFlex’s design creates an elastic resistance to flexion and maintains lordosis, addressing the root problem of excessive instability at the index segment after decompression surgery. It is the only device designed to restore the natural flexion stability of the lumbar spine by mimicking and augmenting the anatomic ligaments to create natural motion across the spine without invasive screws, rods, and bone grafts, add the company.
After completion of the neural decompression (laminectomy) surgery, the LimiFlex DST is implanted through the same incision in order to restore stability while maintaining balanced mobility of the spine. The concept was developed to meet healthcare systems’ increasing demands for improved long-term outcomes with a lower cost of care.
Richard Treadwell, president and CEO of Empirical Spine, said: “Effective lumbar spinal stabilisation that preserves natural motion has long held promise as a major advance in spinal care. But attempts up to now have fallen short. We believe our IDE trial results will remove all doubt that LimiFlex has made that vision a reality.”
The PMA Module III submission provided data from the prospective, multicentre, controlled IDE trial comparing LimiFlex to interbody fusion. The primary outcome is the two-year results of a composite endpoint comprising functional, neurologic, redo surgery, and device integrity components. The study, which enrolled 299 patients across 27 US spine centres, will continue to follow trial participants out to five years of follow-up.
Rick Sasso, the principal investigator for the LimiFlex arm of the IDE trial and a spine surgeon with Indiana Spine Group (Carmel, USA), added: “For years, spine surgeons have struggled with how to preserve segmental motion while stabilising the lumbar spine after decompression, and LimiFlex is the result of learning from other devices that failed to solve the problem.
“We now have a solution that works thanks to a stabilisation mechanism that is different from legacy devices. Plus, because LimiFlex can be surgically implanted in an outpatient setting, it offers a new and much-needed value proposition for payers and patients.”
William Welch, the principal investigator for the fusion arm of the IDE trial and a spine surgeon at Penn Medicine (Philadelphia, USA), commented: “The results from the FDA trial comparing the LimiFlex device to a standardised spinal fusion technique—transforaminal lumbar interbody fusion– following lumbar decompression were favourable for the Limiflex group.
“The published data shows that patients who received the LimiFlex device had durable motion preservation, reduced hospitalisation time, and excellent symptom improvement following lumbar decompression surgery.”