Lumbar Surgery Articles & Analysis
12 news found
The Case Series, authored by Kai-Uwe Lewandrowski, M.D., details a novel endoscopic transforaminal lumbar interbody fusion technique using the VariLift-LX stand-alone expandable interbody fusion device. ...
IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery. ...
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive ...
IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery. ...
Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce FDA approval of an IDE supplement ...
Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article. ...
About the IDCT Trial The IDCT trial is a prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study to evaluate the safety and efficacy of IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration. The trial is underway in 14 centers across 12 states in the U.S. and has completed enrollment of all 60 ...
Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease (DDD). ...
The 3D GraftRasp System is ideal for use in posterolateral or intertransverse lumbar fusion cases. Posterolateral fusion has long been a standard of care to treat lumbar spine disorders and remains one of the most commonly performed procedures. In open posterolateral lumbar fusion surgery, the transverse processes and facet ...
This prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study is designed to evaluate the safety and efficacy of IDCT in patients with symptomatic, single-level, mild to moderate lumbar DDD. All 60 subjects have been treated and no safety issues have been reported. ...
Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® V2 Lateral Interbody Device. The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain ...
Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, expandable stand-alone alternatives to traditional spinal fusion, announced today the full commercial availability of the VariLift-LX System throughout the U.S. VariLift®-LX represents the next generation of Wenzel Spine’s innovative product lines of Expandable Stand-Alone interbody fusion ...