SAN CARLOS, Calif., July 13, 2022 /PRNewswire/ — Empirical Spine, Inc., a medical device company creating a new class of spinal implants that work in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Module II of Premarketing Approval (PMA) accepted and closed by the United States Food & Drug Administration (FDA), a milestone in the commercial approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
The LimiFlex DST is the first surgical option of its kind for patients with grade 1 degenerative spondylolisthesis (degen spondy) with spinal stenosis. Recognized with Breakthrough Device Designation from the FDA, LimiFlex has the potential to offer patients with grade 1 spongy degeneration a better solution compared to current options such as fusion.
“We believe LimiFlex is an exciting advance in stabilization surgery that uses a completely different concept for long-lasting motion preservation to better address the pressing need for improved outcomes with lower cost of care,” said Richard Treadwell. , President and CEO of Empirical Spine. “We are on schedule to submit PMA Module III later this summer, bringing this important innovation closer to commercial availability. This should be good news for the hundreds of thousands of patients suffering from this debilitating disease who have been waiting for a treatment option with lower failure and complication rates.
Flexion, or forward bending, is the main movement of the lumbar spine. Many common activities, including sitting, bending to pick up an object, and many manual tasks, put the lumbar spine in flexion. When a segment of the spine is weakened and unstable, as in degen spondy, the spine flexes unevenly, with a disproportionate amount of motion occurring at the unstable level. Decompression surgery (laminectomy) to relieve neurological 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 anatomical ligaments to create natural, balanced motion through the spine without the use of screws, rods, and invasive bone grafts. After neural decompression/laminectomy is complete, LimiFlex is implanted through the same incision to restore stability while maintaining balanced mobility of the spine.
LimiFlex is an experimental device that is calibrated to work with the spine’s natural biomechanics by simply dynamically increasing the posterior tension band – only when needed – to help keep the facets engaged and strengthen the remaining ligaments. This unique approach focuses on restoring flexion stability while allowing normal segmental motion and halting the progression of spondylolisthesis.
LimiFlex is intended to be an alternative to spinal fusion, which has persistent and well-documented drawbacks, including that it is highly invasive and expensive and carries a high risk of complications and reoperations from surgery. Currently, approximately 140,000 patients, including a disproportionate percentage of women over the age of 65, receive lumbar fusion for spondylic degeneration each year in the United States alone. Despite reported superior results to autonomic decompression, instrumented fusion remains an inappropriate or undesirable invasive surgical option for many patients due to its longer recovery time and postoperative complications. Post-fusion rate of adjacent segment degeneration, with a single major sequelae potentially leading to additional fusion surgery, ranging from 30-50% in the literature.
LimiFlex received CE marking in 2009 and has been implanted with excellent results in over 2,000 European patients. Results to date, including this 10-year experience, show the potential of LimiFlex to provide a robust, minimally invasive, motion-preserving ambulatory solution.
“FDA acceptance and completion of review of the PMA Manufacturing Module demonstrates the maturity and robustness of Empirical Spine’s quality system, including design controls and process validations,” said Louie Fielding, COO, Empirical Spine. “The LimiFlex supply chain has been thoroughly validated and qualified, previously producing commercial products for the European market. With excellent suppliers and experience manufacturing over 2,000 LimiFlex units for the European market, we are confident that we will be ready to meet the US market’s demand for motion-preserving, fusion-free devices when we get FDA approval.
LimitFlexMT is the first dynamic sagittal attachment in its class MT (DST), designed to maintain movement and stability after spinal decompression, without contributing to adjacent level problems, for patients with grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. By increasing the posterior band, LimiFlex creates elastic resistance to flexion and maintains lordosis. For the first time, patients and surgeons will have a minimally invasive option that relieves compressive pain without compromising segmental motion. LimiFlex is compatible with current decompression techniques and can be performed on an outpatient basis, usually in less than 20 minutes. LimiFlex does not involve any screws or bone grafts, which can cause problems by eliminating natural motion between segments of the spine and compromising options for other treatments if needed.
About the Empirical Spine
Empirical Spine, Inc., founded in 2015, is a private company creating a new standard of care in spinal surgery that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life. The company’s LimiFlex™ Dynamic Sagittal Attachment (DST) is the first-of-its-kind surgical option for patients with degenerative spondylolisthesis that no longer requires the outcome and cost compromises that lumbar fusion creates. LimiFlex is a minimally invasive implant designed to stabilize the spine after open decompression, while preserving motion. The company is currently concluding an IDE pivotal trial in the United States. For more information: https://www.limiflex.com/.
Caution: The LimiFlex Dynamic Sagittal Attachment is an investigational device in the United States and is restricted by law to experimental use.
SOURCE Empirical Spine