Julie A. Vetalice, Author at ORTHOWORLD

Innosurge to Distribute DenerveX Throughout Scandinavia

Medovex entered into an agreement with Innosurge for distribution of the DenerveX™ system throughout Scandinavia. DenerveX is designed to provide longer-lasting relief of pain associated with the facet joint.

Apr 05, 2016

NuVasive to Launch Integrated Global Alignment (iGA) Platform in the U.K.

ORTHOFLASH Spine

NuVasive is introducing its Integrated Global Alignment (iGA™) platform in the U.K. iGA packages procedural technology and tools as one platform to help address proper spinal alignment.

Apr 04, 2016

ConforMIS Update on iTotal Hip FDA Submission

Joint Replacement ORTHOFLASH

ConforMIS withdrew its FDA 510(k) application for the iTotal Hip device, and plans to submit a new application in 2H16.

Apr 04, 2016

Zyga Enrolls First Patients in Expanded Clinical Study on Sacroiliac Joint Fusion

ORTHOFLASH Spine

Zyga Technology enrolled the 1st 4 patients in an expanded EVoluSIon Clinical Study evaluating long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

Apr 04, 2016

Vivex Biomedical and Arthrex Enter into Long Term Agreement

Company Updates Competitive Landscape

Vivex Biomedical and Arthrex signed a new multi-year agreement expanding the breadth of Vivex’s products for Arthrex’s distribution.

Mar 31, 2016

Renovis Surgical Receives FDA Clearance of Tesera SC Cervical Interbody Fusion System

ORTHOFLASH Spine

Renovis Surgical received FDA 510(k) clearance to market the Tesera™ SC porous titanium cervical interbody fusion system.

Mar 31, 2016

Extremity Medical Receives FDA 510(k) Clearance for Align Ankle Fusion System

ORTHOFLASH Trauma

Extremity Medical received FDA 510(k) clearance to market the Align Ankle Fusion System™. Initial launch is slated for mid-April 2016.

Mar 30, 2016

Clinical Studies Compare ConforMIS iTotal CR Knee to Off-the-shelf Devices

Joint Replacement ORTHOFLASH

Study results demonstrated that patients implanted with ConforMIS’ iTotal® CR customized total knee exhibited more natural knee kinematics vs. those receiving an "off-the-shelf" total knee.

Mar 30, 2016

Independent Peer-Reviewed 5-Year Follow-Up: 2-Level Cervical Disc Replacement vs. ACDF

ORTHOFLASH Spine

Results from 5-year clinical study comparing cervical total disc replacement (LDR’s Mobi-C) with anterior discectomy and fusion to treat 2-level degenerative disc disease indicated overall success rates of 61% and 31% for cTDR and ACDF, respectively.

Mar 30, 2016

Xtant Medical Receives FDA Clearance of Xspan Laminoplasty Fixation System

ORTHOFLASH Spine

Xtant Medical received FDA 510(k) clearance to market the Xspan™ Laminoplasty Fixation system. Initial limited launch is slated for 2Q16.

Mar 30, 2016

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