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Spinal Level Articles & Analysis

7 news found

Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis

Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis

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. ...

ByEmpirical Spine, Inc.


FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion

FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion

When one segment of the spine is weakened and unstable, as in degen spondy, the spine flexes unevenly, with a disproportionate amount of the motion occurring at the unstable level. Decompression (laminectomy) surgery to relieve neurologic pain (sciatica) contributes to this degenerative spiral by further destabilizing the already unstable level. ...

ByEmpirical Spine, Inc.


Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

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. ...

ByEmpirical Spine, Inc.


Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery

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 ...

ByEmpirical Spine, Inc.


Saluda Medical Announces Highlights from 2021 North American Neuromodulation Society (NANS) Meeting

Saluda Medical Announces Highlights from 2021 North American Neuromodulation Society (NANS) Meeting

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 ...

BySaluda Medical Pty Ltd.


Wenzel Spine Announces Acquisition of Statera Spine

Wenzel Spine Announces Acquisition of Statera Spine

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. ...

ByWenzel Spine, Inc.


Dr. Frank Phillips is First in the World to Use Augmented Reality Surgical Guidance in Minimally Invasive Spine Surgery

Dr. Frank Phillips is First in the World to Use Augmented Reality Surgical Guidance in Minimally Invasive Spine Surgery

Phillips performed a lumbar fusion with spinal implants on a patient with spinal instability at Rush University Medical Center on June 15. ...

ByAugmedics

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