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Spine Stabilization Articles & Analysis

11 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

"Our receipt of the Breakthrough Device Designation is a welcome milestone in realizing our mission to improve the quality of life of patients receiving spine surgery," said Richard Treadwell, CEO of Empirical Spine. "We appreciated the collaboration with FDA as we identified and addressed the key questions required to secure this designation. ...

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. ...

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.


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.


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

“We believe LimiFlex is an exciting advancement in stabilization surgery that uses a completely different concept for durable motion preservation to better meet the pressing need for improved outcomes with a lower cost of care,” says Richard Treadwell, President and CEO of Empirical Spine. ...

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

This creates elastic resistance to flexion and maintains lordosis, giving patients the stabilization their spines need while preserving normal motion. The Dynamic Sagittal Tether is intended to be an alternative to spinal fusion, which has persistent and well-documented drawbacks, including being highly invasive and expensive and carrying a high risk of ...

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

The initiative for the update was led by the International Society for the Advancement of Spine Surgery (ISASS), with support and participation from other spine surgery societies and Empirical Spine. ...

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

LimiFlex does not involve any screws or bone grafts, which eliminate the natural motion between spine segments. Instead, LimiFlex is designed to stabilize the spine without fusing it, thereby preserving motion. The device works by supporting and enhancing the spine’s natural biomechanics with stabilizing ...

ByEmpirical Spine, Inc.


Empirical Spine Closes $10 Million Series B Financing

Empirical Spine Closes $10 Million Series B Financing

Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced the closing of a Series B financing of $10 million. ...

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. ...

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.

The following procedures codes that relate to HBI’s products and services were addressed in this payment update: 0347T Placement of interstitial device(s) in bone for radiostereometric analysis (RSA) 0348T Radiologic examination, radiostereometric analysis (RSA); spine, (includes, cervical,thoracic and lumbosacral, when performed) 0349T Radiologic examination, ...

ByHalifax Biomedical Inc. (HBI)

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