LIMIFLEX™ IDE CLINICAL TRIAL INVESTIGATOR TO PRESENT POSITIVE FINDINGS AT THE NORTH AMERICAN SPINE SOCIETY ANNUAL MEETING

SAN CARLOS, Calif., Oct. 6, 2022 /PRNewswire/ -- 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, will highlight its LimiFlex™ Dynamic Sagittal Tether™ (DST) at the North American Spine Society (NASS) Annual Meeting (Oct. 12 – 15 in Chicago). William Lavelle, MD, Professor of Orthopedic Surgery, Upstate University Hospital, and IDE study investigator, will present interim findings from the US Food & Drug Administration (FDA) LimiFlex DST Investigational Device Exemption (IDE) clinical trial. 

Additionally, the LimiFlex DST will be featured at booth 4137 where attendees can learn more about the first-of-its-kind surgical option that restores both natural flexion and stability of the lumbar spine required after a decompression.

Dr. Lavelle will present research results from the prospective, concurrently controlled, multi-center study evaluating the safety and effectiveness of decompression and stabilization with LimiFlex DST compared to decompression and stabilization from fusion in grade 1 degenerative spondylolisthesis (degen spondy) patients.

"The reduction in disability and faster return to work and activities of daily living may indicate lower perioperative morbidity and faster recovery similar to decompression, while the sustained reduction in disability may indicate clinical durability similar to fusion," says Dr. Lavelle. "These data indicate that LimiFlex DST is a promising alternative to fusion for this large patient population."

The paper, "Return to Work, Activities of Daily Living and Disability Improvement: Twelve-Month Outcomes of an FDA IDE Trial of Decompression and Tension Band Stabilization for Degenerative Spondylolisthesis," was recognized as one of the best papers by the NASS 2022 Scientific Program Committee, which designated the 23 highest-rated abstracts from a record 1,487 submissions.

The interim analysis of the study assessed work status, time to return to work, and activities of daily living (ADL) and change in disability (ODI) for 12 months postoperatively for patients receiving decompression and DST stabilization versus decompression and fusion. Key findings showed that patients who had decompression with DST had:

• Significantly faster return to work and ADLs;
• Significantly lower rate of not working due to their spinal condition; and
• Significant reduction in disability 12 months postoperatively.

"Empirical Spine's vision has been to develop an entirely new category of stabilization surgery that works with the body's natural biomechanics, not against it, like fusion," says Richard Treadwell, President & CEO of Empirical Spine. "Motion matters to patients and is also top of mind for surgeons. We are committed to providing an option that preserves motion while delivering faster recovery and lower cost of care, so everyone wins."

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 is an investigational device that 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, LimiFlex is implanted through the same incision to restore stability while maintaining balanced mobility of the spine.

Recognized with the FDA's Breakthrough Device Designation, LimiFlex had its Premarket Approval (PMA) Module II accepted and closed this summer by the FDA, an important milestone in the commercial approval process.

LimiFlex™ is the first-in-class Dynamic Sagittal Tether™ (DST), designed to maintain motion and stability after spinal decompression, without contributing to adjacent level issues, for grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis. By augmenting 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 in an outpatient setting, typically in less than 20 minutes. LimiFlex does not involve any screws or bone grafts, which can cause issues by eliminating the natural motion between spine segments and compromise options for other treatments if needed.

Empirical Spine, Inc., founded in 2015, is a privately held company creating a new standard of care in spine 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 Tether (DST) is the first-of-its-kind surgical option for degenerative spondylolisthesis patients that no longer forces the trade-offs in outcomes and costs 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 a pivotal IDE trial in the U.S. For more information: https://www.limiflex.com/.

Caution: The LimiFlex Dynamic Sagittal Tether is an investigational device in the United States and is limited by law to investigational use.

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SOURCE Empirical Spine