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Fusion Surgery Articles & Analysis

22 news found

Wenzel Spine Announces Publication of Case Series Detailing Endoscopic Transforaminal Decompression and Fusion Technique with VariLift-LX

Wenzel Spine Announces Publication of Case Series Detailing Endoscopic Transforaminal Decompression and Fusion Technique with VariLift-LX

The Case Series, authored by Kai-Uwe Lewandrowski, M.D., details a novel endoscopic transforaminal lumbar interbody fusion technique using the VariLift-LX stand-alone expandable interbody fusion device. This surgical technique guide shows that it is feasible to perform a percutaneous endoscopically assisted transforaminal decompression and fusion ...

ByWenzel 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

The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery. The trial previously exceeded its target of 135 LimiFlex patients enrolled into the investigational arm and 160 patients enrolled into the control arm of the trial. ...

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 trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after decompression surgery. The trial has reached its target of 135 LimiFlex patients enrolled into the investigational arm of the trial; the control arm will continue enrolling subjects to its target of 160 patients. ...

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 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 LimiFlex patients enrolled into the investigational arm of the trial in December 2019 and the control arm has achieved its target of 160 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

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. “We believe LimiFlex is an exciting advancement in stabilization surgery that uses a completely different concept for durable motion preservation to better meet the ...

ByEmpirical Spine, Inc.


Acumed Acquires Exsomed to Enhance Its Portfolio of Upper Extremity Solutions

Acumed Acquires Exsomed to Enhance Its Portfolio of Upper Extremity Solutions

ArrowPhix™ – ExsoMed’s innovative arrow-shaped screw for functional variable angle DIP fusions. The related ArcPhix™ is an angled screw for strong, functional angle DIP fusions. ...

ByExsoMed Corporation


Cerapedics Announces FDA approval of an IDE supplement

Cerapedics Announces FDA approval of an IDE supplement

Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce FDA approval of an IDE supplement ...

ByCerapedics, Inc.


Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery

Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery

Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article. ...

ByCerapedics, 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

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 surgery-related complications and re-operations. ...

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. When compared with the open technique, the minimally invasive approach can result in decreased pain and blood loss as well as a shorter length of hospitalization. However, the narrower working channel in the MIS technique increases the difficulty of decortication and ...

BySurgentec LLC


Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft

Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft

Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease (DDD). ...

ByCerapedics, 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.


EDGe Surgical Granted U.S. Patent for Next-Generation Awl-in-One Tap

EDGe Surgical Granted U.S. Patent for Next-Generation Awl-in-One Tap

Awl-in-One Tap is a single-use spinal surgery instrument with disposable neuromonitoring EMG system and digital depth measurement built in. The device, which is under development, is intended to be used when creating a screw hole pathway during posterior pedicle spinal fusion surgeries. “As more and more spine fusion ...

ByEDGe Surgical, Inc.


FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion

FDA Clears First Nanotechnology Peek Devices for Spinal Intervertebral Fusion

“Our PEEKplus® is a breakthrough innovation in spinal fusion surgery and the result of a collaborative effort among surgeons, researchers, ion beam scientists, and biomedical engineers,” said Stephen M. ...

ByExogenesis Corporation


SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications

SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications

The 3D GraftRasp System is ideal for use in posterolateral or intertransverse lumbar fusion cases. Posterolateral fusion has long been a standard of care to treat lumbar spine disorders and remains one of the most commonly performed procedures. In open posterolateral lumbar fusion surgery, the transverse processes and facet ...

BySurgentec LLC


Cerapedics Announces Canadian Approval of its next-generation bone graft

Cerapedics Announces Canadian Approval of its next-generation bone graft

” “In addition to an anticipated commercial launch in Canada this October, the technology is currently being studied in our FDA IDE study, ASPIRE, targeting lumbar fusions (TLIF), as previously announced. i-FACTOR+ Matrix is the same technology as the P15-L investigational material in the IDE.,” said Jeffrey Marx, Ph.D., President and Chief Operating Officer of ...

ByCerapedics, 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.

Augmedics, a pioneer in augmented reality surgical image guidance, has announced its groundbreaking xvision Spine System has been successfully used for the first time in a spinal fusion surgery in the United States. The system was used in a spinal surgery procedure by Johns Hopkins University surgeons. xvision, the first Augmented Reality ...

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.

Augmedics, a pioneer in augmented reality surgical image guidance, has announced its groundbreaking xvision Spine System has been successfully used for the first time in a spinal fusion surgery in the United States. The system was used in a spinal surgery procedure by Johns Hopkins University surgeons. xvision, the first Augmented Reality ...

ByAugmedics


Nanovis Announces Commercial Launch of New Nanosurface Technology on Spinal Interbody Implants

Nanovis Announces Commercial Launch of New Nanosurface Technology on Spinal Interbody Implants

Applying these technologies to an entire spine portfolio offers us the potential to offer patients better fixation after fusion surgeries.” – Douglas Pahl, MD, Todd Bonvallet, MD, The Hughston Clinic, Columbus, GA “The FortiCore scaffold has performed well for my patients in lumbar and cervical fusions, providing a large ...

ByNanovis


Pinnacle Spine Group Announces Launch of InFill V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

Pinnacle Spine Group Announces Launch of InFill V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® V2 Lateral Interbody Device. The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain ...

ByPinnacle Spine Group

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