Empirical Spine Completes Full Premarket Approval (PMA) Submission to FDA for LimiFlex™ Dynamic Sagittal Tether™
LimiFlex™ DST™ Is Designed for a New Class of Lumbar Stabilization Surgery That Meets the Demands of Value-Based Care.
SAN CARLOS, Calif., Dec. 19, 2022 /PRNewswire/ — Empirical Spine, Inc., a medical device company creating a new class of spinal implant, recently completed the final step in the U.S. Food & Drug Administration (FDA) submission process for the LimiFlex™ Dynamic Sagittal Tether™ (DST). The Premarket Approval (PMA) submission included Module III, with data and analysis of the two-year results from the pivotal Investigational Device Exemption (IDE) clinical trial comparing LimiFlex DST stabilization versus fusion surgery for degenerative spondylolisthesis (degen spondy) patients with spinal stenosis.
The LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical option for this specific patient population. The device previously received the FDA’s Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization technologies.
The LimiFlex DST uses a completely different concept than past devices to provide durable symptom resolution while preserving spinal motion. LimiFlex’s design creates an elastic resistance to flexion and maintains lordosis, addressing the root problem of excessive instability at the index segment after decompression surgery. It is the only device designed to restore the natural flexion stability of the lumbar spine by mimicking and augmenting the anatomic ligaments to create natural motion across the spine without invasive screws, rods, and bone grafts. After completion of the neural decompression (laminectomy) surgery, the LimiFlex DST is implanted through the same incision to restore stability while maintaining balanced mobility of the spine. The concept was developed to meet healthcare systems’ increasing demands for improved long-term outcomes with a lower cost of care.
“Effective lumbar spinal stabilization that preserves natural motion has long held promise as a major advance in spinal care,” says Richard Treadwell, President & CEO of Empirical Spine. “But attempts up to now have fallen short. We believe our IDE trial results will remove all doubt that LimiFlex has made that vision a reality.”
The PMA Module III submission provided data from the prospective, multi-center, controlled IDE trial comparing LimiFlex to interbody fusion, considered the standard of care. The primary outcome is the two-year results of a composite endpoint comprising functional, neurologic, redo surgery, and device integrity components. The study, which enrolled 299 patients across 27 U.S. spine centers, will continue to follow trial participants out to five years of follow-up.
“For years, spine surgeons have struggled with how to preserve segmental motion while stabilizing the lumbar spine after decompression, and LimiFlex is the result of learning from other devices that failed to solve the problem,” said Rick Sasso, M.D., the Principal Investigator for the LimiFlex arm of the IDE Trial and spine surgeon with Indiana Spine Group. “We now have a solution that works thanks to a stabilization mechanism that is different from legacy devices. Plus, because LimiFlex can be surgically implanted in an outpatient setting, it offers a new and much-needed value proposition for payers and patients.”
“The results from the FDA trial comparing the LimiFlex device to a standardized spinal fusion technique – transforaminal lumbar interbody fusion-TLIF – following lumbar decompression were favorable for the Limiflex group,” says William Welch, M.D., the Principal Investigator for the fusion arm of the IDE trial and Penn Medicine spine surgeon. “The published data shows that patients who received the LimiFlex device had durable motion preservation, reduced hospitalization time, and excellent symptom improvement following lumbar decompression surgery.”
Completing the entire PMA submission is an important milestone in the commercial approval process for LimiFlex DST. Empirical Spine’s other 2022 accomplishments include the submission and acceptance by the FDA of Module II and the presentation of the positive interim findings from the IDE trial at NASS 2022, CNS, and the Mazma Spine Summit.
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.
About Empirical Spine
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.
SOURCE Empirical Spine