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Lumbar Degenerative Articles & Analysis

6 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

LimiFlex is poised to become a powerful new tool to treat degenerative spondylolisthesis in an effective and less invasive way than the current standard." LimiFlex, new to the US Market, is an investigational device designed as an alternative to spinal fusion for patients receiving surgical decompression for grade 1 lumbar degenerative ...

ByEmpirical Spine, Inc.


Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis

Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis

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 ...

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

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 longer recovery time ...

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

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. ...

ByEmpirical Spine, Inc.


Empirical Spine Presents Data from Study of the LimiFlex Tension Band at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021

Empirical Spine Presents Data from Study of the LimiFlex Tension Band at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021

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. ...

ByEmpirical Spine, Inc.

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