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Lumbar Decompression Articles & Analysis

12 news found

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.


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, 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 spondylolisthesis with 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

IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery. The trial has reached its target ...

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

IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery. The trial reached its target of 135 ...

ByEmpirical Spine, Inc.


Landmark Survey by Stagwell`s The Harris Poll Estimates More Than 72.3 Million U.S. Adults Suffer from Chronic Low Back Pain - Greater than Arthritis, Diabetes, or Heart Disease and with Debilitating Impact on Quality of Life

Landmark Survey by Stagwell`s The Harris Poll Estimates More Than 72.3 Million U.S. Adults Suffer from Chronic Low Back Pain - Greater than Arthritis, Diabetes, or Heart Disease and with Debilitating Impact on Quality of Life

Centers for Disease Control noting inadequate effectiveness and inherent risks,6 and only 5% utilizing minimally invasive lumbar decompression treatment options which are now considered appropriate for earlier use.7 Other key findings (Click here for Executive Summary and here for Presentation) include: CLBP Has Significant Impact on Mobility and Long-term ...

ByVertos Medical, 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.


Surgentec releases whitepaper featuring A Novel Decortication and Graft Delivery Technique for Minimally Invasive Spine Fusion Surgery

Surgentec releases whitepaper featuring A Novel Decortication and Graft Delivery Technique for Minimally Invasive Spine Fusion Surgery

Minimally invasive (MIS) lumbar fusion has become a popular alternative to traditional methods of lumbar decompression and fusion. ...

BySurgentec LLC


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.


Publication of Two-Year EVOKE Double-Blind Randomized Controlled Trial Results in JAMA Neurology Demonstrate Sustained Superiority of Evoke® Closed-Loop over Open-Loop Spinal Cord Stimulation

Publication of Two-Year EVOKE Double-Blind Randomized Controlled Trial Results in JAMA Neurology Demonstrate Sustained Superiority of Evoke® Closed-Loop over Open-Loop Spinal Cord Stimulation

Significant findings of Evoke ECAP-controlled closed-loop in the EVOKE Study at 24 months include: Superiority in treatment of overall back and leg pain and long-term pain reduction Highest long-term responder (≥50% relief) and high responder (≥80% relief) rates, 84% and 50%, respectively Highest reported improvements in overall quality of life, pain relief, ability to perform daily ...

BySaluda Medical Pty Ltd.


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

“Patients prefer motion-preserving surgeries that are less invasive and have faster recovery than lumbar fusion,” commented Dr. Bae. “LimiFlex is an appealing potential alternative for patients with degenerative spondylolisthesis.” About LimiFlex The LimiFlex Tension Band is a new, investigational device designed as an alternative to spinal fusion for ...

ByEmpirical Spine, Inc.


First Augmented Reality Spine Surgery Using FDA-Cleared Augmedics xvision Spine System Completed in U.S.

First Augmented Reality Spine Surgery Using FDA-Cleared Augmedics xvision Spine System Completed in U.S.

The surgery with the xvision Spine System was a posterior lumbar decompression, slipped vertebrae (spondylolisthesis) correction, and fusion. ...

ByAugmedics


First Augmented Reality Spine Surgery Using FDA-Cleared Augmedics xvision Spine System Completed in U.S.

First Augmented Reality Spine Surgery Using FDA-Cleared Augmedics xvision Spine System Completed in U.S.

The surgery with the xvision Spine System was a posterior lumbar decompression, slipped vertebrae (spondylolisthesis) correction, and fusion. ...

ByAugmedics

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