Empirical Spine recently had its pre-market approval (PMA) Module II accepted and closed by the US Food and Drug Administration (FDA), an important milestone in the commercial approval process for its LimiFlex Dynamic Sagittal Tether (DST).
According to a company press release, the LimiFlex DST is the first-of-its-kind surgical option for grade one degenerative spondylolisthesis patients with spinal stenosis. Granted FDA breakthrough device designation, LimiFlex has the potential to offer grade one degenerative spondylolisthesis patients a better solution compared to current options such as fusion, the company adds.
Richard Treadwell, president and CEO of Empirical Spine, said: “We believe LimiFlex is an exciting advancement in stabilisation surgery that uses a completely different concept for durable motion preservation to better meet the pressing need for improved outcomes with a lower cost of care.
“We are on schedule to submit PMA Module III later this summer, bringing this significant innovation one step closer to commercial availability. This should be welcome news to the hundreds of thousands of patients suffering from this debilitating condition who have been waiting for a treatment option with lower failure and complication rates.”
The LimiFlex DST mimics and augments the anatomic ligaments to create natural, balanced motion across the spine without the use of invasive screws, rods, and bone grafts, say Empirical Spine. After completion of the neural decompression/laminectomy, LimiFlex is implanted through the same incision to restore stability while maintaining balanced mobility of the spine.
It is designed to work with the natural biomechanics of the spine by augmenting the posterior tension band only when needed, to help keep the facets engaged and add strength to the remaining ligaments. This approach focuses on restoring stability in flexion while allowing for normal segmental motion and halting progression of the spondylolisthesis.
LimiFlex is intended to be an alternative to spinal fusion. The device received CE mark in 2009 and has since been implanted in more than 2,000 European patients.
Louie Fielding, Empirical Spine’s chief operating officer, added: “FDA acceptance and closure of the review of the PMA Manufacturing Module demonstrates the maturity and robustness of Empirical Spine’s quality system, including design controls and process validations.
“The LimiFlex supply chain was thoroughly validated and qualified, previously producing commercial product for the European market. With excellent suppliers and experience manufacturing more than 2,000 LimiFlex units for the European market, we are confident that we will be ready to meet the US market demand for motion-preserving, non-fusion devices when we obtain approval from the FDA.”