SAN CARLOS, Calif., July 13, 2022 /PRNewswire/ — Empirical Backbone, Inc., a medical gadget firm creating a brand new class of spinal implant that works in parallel with the pure buildings of the backbone to revive performance and optimize high quality of life, not too long ago had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an necessary milestone within the industrial approval course of for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
The LimiFlex DST is the first-of-its-kind surgical possibility for grade 1 degenerative spondylolisthesis (degen spondy) sufferers with spinal stenosis. Acknowledged with FDA’s Breakthrough Machine Designation, LimiFlex has the potential to supply grade 1 degen spondy sufferers a greater resolution in comparison with present choices corresponding to fusion.
“We consider LimiFlex is an thrilling development in stabilization surgical procedure that makes use of a totally totally different idea for sturdy movement preservation to raised meet the urgent want for improved outcomes with a decrease value of care,” says Richard Treadwell, President and CEO of Empirical Backbone. “We’re on schedule to submit PMA Module III later this summer time, bringing this vital innovation one step nearer to industrial availability. This needs to be welcome information to the lots of of hundreds of sufferers affected by this debilitating situation who’ve been ready for a therapy possibility with decrease failure and complication charges.”
Flexion, or ahead bending, is the first movement of the lumbar backbone. Many frequent actions, together with sitting, bending over to select up an object and lots of guide duties, put the lumbar backbone into flexion. When one phase of the backbone is weakened and unstable, as in degen spondy, the backbone flexes erratically, with a disproportionate quantity of the movement occurring on the unstable stage. Decompression (laminectomy) surgical procedure to alleviate neurologic ache (sciatica) contributes to this degenerative spiral by additional destabilizing the already unstable stage.
The LimiFlex DST is the one gadget designed to revive the pure flexion stability of the lumbar backbone. The LimiFlex DST mimics and augments the anatomic ligaments to create pure, balanced movement throughout the backbone with out using invasive screws, rods, and bone grafts. After completion of the neural decompression/laminectomy, LimiFlex is implanted via the identical incision to revive stability whereas sustaining balanced mobility of the backbone.
LimiFlex is an investigational gadget that’s calibrated to work with the pure biomechanics of the backbone by merely augmenting the posterior rigidity band in a dynamic method—solely when wanted—to assist preserve the sides engaged and add power to the remaining ligaments. This distinctive method focuses on restoring stability in flexion whereas permitting for regular segmental movement and halting development of the spondylolisthesis.
LimiFlex is meant to be a substitute for spinal fusion, which has persistent and well-documented drawbacks, together with being extremely invasive and costly and carrying a excessive danger of surgery-related issues and re-operations. At present, an estimated 140,000 sufferers, of which a disproportionate % are ladies over age 65, obtain lumbar fusion yearly for degen spondy within the US alone. Regardless of reported outcomes superior to standalone decompression, instrumented fusion stays an invasive surgical possibility not acceptable or fascinating for a lot of sufferers resulting from its longer restoration time and postoperative issues. Put up-fusion charges of adjoining phase degeneration, only one necessary sequela that may result in extra fusion surgical procedure, starting from 30-50% within the literature.
LimiFlex acquired the CE Mark in 2009 and has been implanted with wonderful leads to greater than 2,000 European sufferers. Outcomes up to now, together with this 10-year expertise, present the potential for LimiFlex to offer a strong, motion-preserving, minimally invasive, outpatient resolution.
“FDA acceptance and closure of the overview of the PMA Manufacturing Module demonstrates the maturity and robustness of Empirical Backbone’s high quality system, together with design controls and course of validations,” says Louie Fielding, COO, Empirical Backbone. “The LimiFlex provide chain was completely validated and certified, beforehand producing industrial product for the European market. With wonderful suppliers and expertise manufacturing greater than 2,000 LimiFlex items for the European market, we’re assured that we’ll be prepared to satisfy the US market demand for motion-preserving, non-fusion gadgets after we receive approval from the FDA.”
LimiFlexTM is the first-in-class Dynamic Sagittal Tether TM (DST), designed to keep up 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 strategies and might be carried out in an outpatient setting, usually in lower than 20 minutes. LimiFlex doesn’t contain any screws or bone grafts, which may trigger points by eliminating the pure movement between backbone segments and compromise choices for different therapies if wanted.
About Empirical Backbone
Empirical Backbone, Inc., based in 2015, is a privately held firm creating a brand new normal of care in backbone surgical procedure that works in parallel with the pure buildings of the backbone 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 backbone after open decompression, whereas preserving movement. The corporate is presently concluding a pivotal IDE trial within the U.S. For extra info: https://www.limiflex.com/.
Warning: The LimiFlex Dynamic Sagittal Tether is an investigational gadget in america and is proscribed by legislation to investigational use.
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