Spinal Level Articles & Analysis
5 news found
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band. ...
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. ...
Key potential benefits cited in the BDD application include less invasive and shorter surgery, improved intra- and post-operative outcomes, reduction or elimination of hospital stay, and improved quality of life, including motion-preservation at the affected spinal level. The FDA's Breakthrough Devices Program accelerates the development of medical devices with ...
Additionally, a record number of posters and presentations at NANS 2021 were focused on evoked compound action potential (ECAP, the patient’s unique spinal cord response to electrical stimulation) recordings for spinal cord stimulation (SCS). “As the pioneers in closed-loop spinal cord stimulation, we are thrilled to see the growing ...
Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced that it has completed the acquisition of Statera Spine, a pre-operative diagnostics and quantitative data software solution that improves treatment decisions for spine patients. ...