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Spinal Stabilization Articles & Analysis

11 news found

Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

Empirical Spine Completes Enrollment in Pivotal IDE Clinical Trial Studying LimiFlex in Degenerative Spondylolisthesis

The device may offer a minimally invasive way to stabilize the spine yet preserve motion. Many patients are extremely interested in less invasive stabilization options that avoid the complications of fusion, so they are attracted to LimiFlex." ...

ByEmpirical Spine, Inc.


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.


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 who receive ...

ByEmpirical Spine, Inc.


Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

Empirical Spine Completes Investigational Arm Enrollment In Pivotal IDE Clinical Trial Studying LimiFlex In Degenerative Spondylolisthesis

The device may offer a minimally invasive way to stabilize the spine yet preserve motion. Many patients are extremely interested in less invasive stabilization options that avoid the complications of fusion, so they are attracted to LimiFlex. ...

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

This unique approach focuses on restoring stability in flexion while allowing for normal segmental motion and halting progression of the spondylolisthesis. ...

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. This creates elastic resistance to flexion and maintains lordosis, giving patients the ...

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

” About LimiFlex The LimiFlex Tension Band is a new, investigational device designed as an alternative to spinal fusion for patients receiving surgical decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. ...

ByEmpirical Spine, Inc.


Empirical Spine Closes $10 Million Series B Financing

Empirical Spine Closes $10 Million Series B Financing

In my practice, I have seen increased interest in these benefits from both patients and physicians." Traditional means of stabilizing the spine after decompression surgery involve lengthy, invasive procedures that use bone graft material, combined with instrumentation such as pedicle screws and rods, to fuse two or more vertebrae together. The LimiFlex was developed to offer a ...

ByEmpirical Spine, Inc.


Sharp HealthCare launches new Implant Stability Assessment Service

Sharp HealthCare launches new Implant Stability Assessment Service

(HBI), a Nova Scotia-based company specializing in precision assessment of spine and joint-replacement micro-instability, is pleased to announce that Sharp HealthCare (Sharp) will be implementing HBI’s innovative Implant Stability Assessment Kit at their Coronado, California facility. Sharp HealthCare is a not-for-profit integrated regional health care delivery system ...

ByHalifax Biomedical Inc. (HBI)


Centers for Medicare and Medicaid Services Issues Updated Payment Guidelines for Halifax Biomedical Services.

Centers for Medicare and Medicaid Services Issues Updated Payment Guidelines for Halifax Biomedical Services.

HBI is a world leading provider of equipment and services for evaluating orthopaedic and spine implant stability and fixation using proprietary Stereo Radiography (SR) imaging technology (HALIFAX exams). HBI focuses on two clinical problems; early detection of implant loosening for total hip and knee replacements, and quantification of instability of the spinal ...

ByHalifax Biomedical Inc. (HBI)

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