San Carlos, Calif. (July 12, 2022) – 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. “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.”
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