Saturday, September 23, 2023
Saturday, September 23, 2023

FDA Accepts & Closes LimiFlex PMA Module

Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).

The LimiFlex DST is the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis. Recognized with FDA’s Breakthrough Device Designation, LimiFlex has the potential to offer grade 1 degen spondy patients a better solution compared to current options such as fusion.

“We believe LimiFlex is an exciting advancement in stabilization 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,” says Richard Treadwell, President and CEO of Empirical Spine.

He added, “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.”

Flexion, or forward bending, is the primary motion of the lumbar spine. Many common activities, including sitting, bending over to pick up an object and many manual tasks, put the lumbar spine into flexion. When one segment of the spine is weakened and unstable, as in degen spondy, the spine flexes unevenly, with a disproportionate amount of the motion occurring at the unstable level.  Decompression (laminectomy) surgery to relieve neurologic pain (sciatica) contributes to this degenerative spiral by further destabilizing the already unstable level.

The LimiFlex DST is the only device designed to restore the natural flexion stability of the lumbar spine. 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. After completion of the neural decompression/laminectomy, LimiFlex is implanted through the same incision to restore stability while maintaining balanced mobility of the spine.

LimiFlex is an investigational device that is calibrated to work with the natural biomechanics of the spine by simply augmenting the posterior tension band in a dynamic manner—only when needed—to help keep the facets engaged and add strength to the remaining ligaments. This unique 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, which has persistent and well-documented drawbacks, including being highly invasive and expensive and carrying a high risk of surgery-related complications and re-operations. Currently, an estimated 140,000 patients, of which a disproportionate percent are women over age 65, receive lumbar fusion annually for degen spondy 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, ranging from 30-50% in the literature.

LimiFlex received the CE Mark in 2009 and has been implanted with excellent results in more than 2,000 European patients. Results to date, including this 10-year experience, show the potential for LimiFlex to provide a robust, motion-preserving, minimally invasive, outpatient solution.

“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,” says Louie Fielding, COO, Empirical Spine. “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.”

Other FDA-related news can be found here.

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