Lumbar Fusion Articles & Analysis
24 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. ...
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. ...
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. ...
Currently, an estimated 140,000 patients, of which a disproportionate percent are women over age 65, receive lumbar fusion annually for degen spondy in the US alone. Despite reported results superior to standalone decompression, instrumented fusion remains an invasive surgical option not appropriate or desirable for many patients due to its ...
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. The data demonstrate that elderly patients in Denmark treated with ...
LimiFlex is an investigational device targeting grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis. It is designed to restore natural segmental motion and stability after lumbar decompression by augmenting the posterior tension band. ...
Minimally invasive (MIS) lumbar fusion has become a popular alternative to traditional methods of lumbar decompression and fusion. ...
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). ...
LimiFlex is an investigational device targeting grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis, designed to restore natural segmental motion and stability after an open lumbar decompression by augmenting the posterior tension band. ...
Significant findings of Evoke ECAP-controlled closed-loop in the EVOKE Study at 24 months include: Superiority in treatment of overall back and leg pain and long-term pain reduction Highest long-term responder (≥50% relief) and high responder (≥80% relief) rates, 84% and 50%, respectively Highest reported improvements in overall quality of life, pain relief, ability to perform daily ...
Empirical Spine, Inc., a Silicon-Valley based medical technology company, announced today that data from the IDE study of the company’s LimiFlex Tension Band for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis, was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021. ...
The LimiFlex IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the LimiFlex Paraspinous Tension Band compared to transforaminal lumbar interbody fusion (TLIF) in patients suffering from degenerative spondylolisthesis and lumbar spinal stenosis. ...
Cerapedics Cerapedics developed the i-Factor peptide enhanced bone graft that is already FDA approved for use in cervical fusion and Cerapedics is pursuing a lumbar fusion indication. The Westminster, CO-based company also recently received a FDA breakthrough device designation for its P-15L bone graft for the treatment of degenerative disc ...
Food and Drug Administration (FDA) premarket approval (PMA) application in 2015 only for use in single-level anterior cervical fusion procedures. “In addition to the commercial launch in Canada, the latest i-FACTOR+ MATRIX generation is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously ...
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 ...
” “In addition to an anticipated commercial launch in Canada this October, the technology is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced. i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE.,” said Jeffrey Marx, Ph.D., President and Chief ...
Using this new technology, Dr. Phillips performed a lumbar fusion with spinal implants on a patient with spinal instability at Rush University Medical Center on June 15. ...
I’m looking forward to pairing Nano FortiCore lumbar interbodies with the bioceramic nanotube enhanced Nano FortiFix pedicle screws Nanovis is bringing to market soon”. ...
ByNanovis