Empirical Spine recently had its Premarket Approval (PMA) Module II accepted and closed by FDA, a milestone in the commercial approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
LimiFlex DST is reportedly the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis patients with spinal stenosis. Recognized with FDA’s Breakthrough Device Designation, LimiFlex has the potential to offer these patients an alternative to fusion.
The LimiFlex PMA Module III will be submitted later this summer.
Richard Treadwell, President and CEO, said, “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.”
Empirical Spine recently had its Premarket Approval (PMA) Module II accepted and closed by FDA, a milestone in the commercial approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
LimiFlex DST is reportedly the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis patients with spinal stenosis. Recognized with...
Empirical Spine recently had its Premarket Approval (PMA) Module II accepted and closed by FDA, a milestone in the commercial approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
LimiFlex DST is reportedly the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis patients with spinal stenosis. Recognized with FDA’s Breakthrough Device Designation, LimiFlex has the potential to offer these patients an alternative to fusion.
The LimiFlex PMA Module III will be submitted later this summer.
Richard Treadwell, President and CEO, said, “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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