Julie Vetalice, Author at ORTHOWORLD

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

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

Results from 6-month ActiPatch Product Observation Study

Company Updates Competitive Landscape

Results from a 6-month study observing BioElectronics’ ActiPatch® musculoskeletal pain therapy device indicated an average 61% reduction in pain for >90% of participants, a decrease in doctor visits, etc.

Mar 29, 2016

Anika Therapeutics Obtains CE Mark Approval for Cingal to Treat Knee OA Pain

Orthobiologics ORTHOFLASH

Anika Therapeutics received CE Mark approval for CINGAL® as a medical device to treat knee osteoarthritis pain.

Mar 29, 2016

Bone Therapeutics Reports Initial Efficacy from PREOB® Phase IIA Trial

Orthobiologics ORTHOFLASH

Initial 12-month efficacy results from a Phase IIA trial demonstrate positive effects on pain and osteoporosis blood markers from a single administration of Bone Therapeutics’ PREOB® autologous osteoblastic cell therapy.

Mar 29, 2016

U.S. Government Extends Biomet’s Deferred Prosecution Agreement

Company Updates Competitive Landscape

Zimmer Biomet announced that the U.S. DOJ and SEC are continuing evaluation of the company’s past conduct in Brazil and Mexico, regarding possible violations of the Foreign Corrupt Practices Act.

Mar 29, 2016

Tenex Receives FDA Clearance for TX2 MicroTip to Treat Chronic Tendinosis

ORTHOFLASH Sports Medicine

Tenex Health received FDA 510(k) clearance to market the TX2 MicroTip, with application to treat tendinosis of the shoulder and hip in an outpatient procedure. Launch is slated for mid-2016.

Mar 29, 2016