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Spinal Stenosis Articles & Analysis

14 news found

What to Expect for an Epidural Injection

What to Expect for an Epidural Injection

The epidural injection site will vary depending on the patients’ needs. Most spinal injections specifically are performed as a portion of a more comprehensive treatment program, aiming to boost spinal mobility and cure the patient of chronic pain levels. ...

ByMilestone Scientific, 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. ...

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 LimiFlexâ„¢ 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

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 LimiFlexâ„¢ Paraspinous Tension Band. ...

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. ...

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 Negative Impact on Life More than ...

ByVertos Medical, 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

The LimiFlex DST is the first-of-its-kind surgical option for grade 1 degenerative spondylolisthesis (degen spondy) patients with spinal stenosis. Recognized with FDA’s Breakthrough Device Designation, LimiFlex has the potential to offer grade 1 degen spondy patients a better solution compared to current options such as fusion. ...

ByEmpirical Spine, Inc.


Optimizing Patient Outcomes - Tips from Advanced Practice Provider to Communicate Appropriate Patient Expectations After the mild Treatment

Optimizing Patient Outcomes - Tips from Advanced Practice Provider to Communicate Appropriate Patient Expectations After the mild Treatment

As an Advanced Practice Provider (APP), you are an integral part in helping patients with lumbar spinal stenosis (LSS) get on the path to lasting relief. In this webinar workshop, led by our panel of mild® experts, APPs Ashley Comer, NP, Marie Zambelli, NP, Kelsey Kimball, PA, Lauren Cote, NP, Patrick McGinn, PA, Kristen Klein, NP, discuss how patient ...

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.


APP Imaging Workshop - A Collaborative Approach to mild Patient Selection

APP Imaging Workshop - A Collaborative Approach to mild Patient Selection

Interventional Pain Management is a fast-growing specialty. As new lumbar spinal stenosis (LSS) procedures become available, practices are evolving the way they collaborate and work together to optimize patient care. ...

ByVertos Medical, 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.


Empirical Spine Closes $10 Million Series B Financing

Empirical Spine Closes $10 Million Series B Financing

The LimiFlex IDE trial is a prospective, multi-center, controlled clinical trial studying the safety and efficacy of the LimiFlex Paraspinous Tension Band compared to transforaminal lumbar interbody fusion (TLIF) in patients suffering from degenerative spondylolisthesis and lumbar spinal stenosis. The study primary endpoint is a comparison of success of a ...

ByEmpirical Spine, Inc.


The Ultimate List of Attractive MedTech M&A Targets

The Ultimate List of Attractive MedTech M&A Targets

The device is located under the scalp, much like a cerebral spinal fluid (CSF) shunt. In March, the company received FDA breakthrough device designation for its ReFlow System Mini intended for the treatment of CSF disorders requiring shunting, such as hydrocephalus. ...

ByAnuncia Medical, Inc.

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