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Orthopedic and Dental Industry News Complete Archive »

Musculoskeletal News Roundup 12-Nov-15 BY BLAKE MOSSY, NOVEMBER 12, 2015

REGULATORY
Interventional Spine received clearance from the FDA for its next generation Opicage Expandable Interbody Fusion Device, an enhanced version of the original Opticage. The system aims to provide improved ability to deliver graft material through implant expansion, and improved ergonomics.

SI-BONE received clearance from the FDA for its iFuse Implant System to include in its indication statement that “Clinical studies have demonstrated that treatment with the iFuse Implant Sytem improved pain, patient function and quality of life at 12 months post-implantation.”

VeritFlex announced that the AMA CPT Editorial Panel has approved Category 1 CPT codes to describe one and two level insertion of interspinous spacers, replacing the existing Category III CPT codes. The company aims to provide advancement in minimally invasive solutions for the treatment of lumbar spinal stenosis.

PRODUCT INTRODUCTION & UPDATE
DePuy Synthes launched its ADVANTAGE Outpatient Solutions Program for joint replacement in ambulatory surgical centers and outpatient hospitals. The program’s procedures aim to improve patient outcomes, speed up recovery, manage costs, improve efficiency and increase patient satisfaction.

INTELLECTUAL PROPERTY
KATOR received patent from the United States Patent and Trademark Office for its Suture Anchor, a novel suture anchor device that eliminates the need for knot tying and locks different portions of suture to different portions of the anchor. This technology enables surgeons to achieve strong tissue-to-bone repairs with fewer suture anchors.

CLINICAL
Amedica submitted to the FDA the 24-month, 2 year clinical data outcomes from its CASCADE study, a blinded, randomized clinical trial comparing cervical fusion outcomes between the company’s composite silicon nitride devices manufactured with an integrated core of cancellous structured ceramic (CsC), to the existing standard PEEK.

DISTRIBUTION
Orthozon entered a distribution agreement appointing GM Medical Pacific Limited as the exclusive distributor of the company’s LUMIERE Minimally Invasive Access System (“LUMIERE SYSTEM”) in the Asia-Pacific region. The system is a single-use sterile-packed instrument, featuring built-in fiber optic lighting and rotatable translucent blades to support a reduced risk of muscle damage.

COLLABORATION
Bactiguard entered into a license agreement with Vigilenzx Medical to develop anti-infective coated orthopaedic trauma implant sets serving the Asean region. Bactiguard will initially provide the coated implants, while Vigilenz will manage the clinical trials and CE Mark process. Upon product launch, Bactiguard will receive royalties.

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