LimiFlex™ DST™ Is Designed for a New Class of Lumbar Stabilization Surgical procedure That Meets the Calls for of Worth-Primarily based Care.
SAN CARLOS, Calif., Dec. 19, 2022 /PRNewswire/ — Empirical Backbone, Inc., a medical machine firm creating a brand new class of spinal implant, just lately accomplished the ultimate step within the U.S. Food & Drug Administration (FDA) submission course of for the LimiFlex™ Dynamic Sagittal Tether™ (DST). The Premarket Approval (PMA) submission included Module III, with knowledge and evaluation of the two-year outcomes from the pivotal Investigational System Exemption (IDE) medical trial evaluating LimiFlex DST stabilization versus fusion surgical procedure for degenerative spondylolisthesis (degen spondy) sufferers with spinal stenosis.
The LimiFlex DST is the first-of-its-kind minimally invasive, outpatient surgical possibility for this particular affected person inhabitants. The machine beforehand obtained the FDA’s Breakthrough Designation for its potential to supply vital benefits over presently authorized spinal stabilization applied sciences.
The LimiFlex DST makes use of a totally totally different idea than previous gadgets to supply sturdy symptom decision whereas preserving spinal movement. LimiFlex’s design creates an elastic resistance to flexion and maintains lordosis, addressing the basis downside of extreme instability on the index section after decompression surgical procedure. It’s the solely machine designed to revive the pure flexion stability of the lumbar spine by mimicking and augmenting the anatomic ligaments to create pure movement throughout the spine with out invasive screws, rods, and bone grafts. After completion of the neural decompression (laminectomy) surgical procedure, the LimiFlex DST is implanted by the identical incision to revive stability whereas sustaining balanced mobility of the spine. The idea was developed to satisfy healthcare programs’ rising calls for for improved long-term outcomes with a decrease value of care.
“Efficient lumbar spinal stabilization that preserves pure movement has lengthy held promise as a serious advance in spinal care,” says Richard Treadwell, President & CEO of Empirical Backbone. “However makes an attempt so far have fallen quick. We imagine our IDE trial outcomes will take away all doubt that LimiFlex has made that imaginative and prescient a actuality.”
The PMA Module III submission offered knowledge from the possible, multi-center, managed IDE trial evaluating LimiFlex to interbody fusion, thought of the usual of care. The first consequence is the two-year outcomes of a composite endpoint comprising purposeful, neurologic, redo surgical procedure, and machine integrity parts. The examine, which enrolled 299 sufferers throughout 27 U.S. spine facilities, will proceed to comply with trial contributors out to 5 years of follow-up.
“For years, spine surgeons have struggled with tips on how to protect segmental movement whereas stabilizing the lumbar spine after decompression, and LimiFlex is the results of studying from different gadgets that failed to unravel the issue,” stated Rick Sasso, M.D., the Principal Investigator for the LimiFlex arm of the IDE Trial and spine surgeon with Indiana Backbone Group. “We now have an answer that works due to a stabilization mechanism that’s totally different from legacy gadgets. Plus, as a result of LimiFlex might be surgically implanted in an outpatient setting, it provides a brand new and much-needed worth proposition for payers and sufferers.”
“The outcomes from the FDA trial evaluating the LimiFlex machine to a standardized spinal fusion method – transforaminal lumbar interbody fusion-TLIF – following lumbar decompression had been favorable for the Limiflex group,” says William Welch, M.D., the Principal Investigator for the fusion arm of the IDE trial and Penn Medication spine surgeon. “The printed knowledge reveals that sufferers who obtained the LimiFlex machine had sturdy movement preservation, lowered hospitalization time, and wonderful symptom enchancment following lumbar decompression surgical procedure.”
Finishing your entire PMA submission is a vital milestone within the business approval course of for LimiFlex DST. Empirical Backbone’s different 2022 accomplishments embody the submission and acceptance by the FDA of Module II and the presentation of the constructive interim findings from the IDE trial at NASS 2022, CNS, and the Mazma Backbone Summit.
LimiFlex™ is the first-in-class Dynamic Sagittal Tether™ (DST), designed to take care of movement and stability after spinal decompression, with out contributing to adjoining stage points, for grade 1 lumbar degenerative spondylolisthesis sufferers with spinal stenosis. By augmenting the posterior band, LimiFlex creates elastic resistance to flexion and maintains lordosis. For the primary time, sufferers and surgeons may have a minimally invasive possibility that relieves compressive ache with out compromising segmental movement. LimiFlex is appropriate with present decompression methods and might be carried out in an outpatient setting, sometimes in lower than 20 minutes. LimiFlex doesn’t contain any screws or bone grafts, which might trigger points by eliminating the pure movement between spine segments and compromise choices for different remedies if wanted.
About Empirical Backbone
Empirical Backbone, Inc., based in 2015, is a privately held firm creating a brand new commonplace of care in spine surgical procedure that works in parallel with the pure buildings of the spine to revive performance and optimize high quality of life. The corporate’s LimiFlex™ Dynamic Sagittal Tether (DST) is the first-of-its-kind surgical possibility for degenerative spondylolisthesis sufferers that not forces the trade-offs in outcomes and prices that lumbar fusion creates. LimiFlex is a minimally invasive implant designed to stabilize the spine after open decompression, whereas preserving movement. The corporate is presently concluding a pivotal IDE trial within the U.S. For extra data: https://www.limiflex.com/.
Warning: The LimiFlex Dynamic Sagittal Tether is an investigational machine in america and is proscribed by regulation to investigational use.