Zimmer Spine Green-Lights U.S. Launch of Virage OCT Spinal Fixation System
Zimmer Spine on Monday announced the preliminary U.S. launch of its VirageOCT Spinal Fixation System, following the receipt of FDA 510(k) clearance on June 2.
The system simplifies screw implantation and rod alignment thanks to its omnidirectional extreme-angle screw and friction-fit technology, the Minneapolis company says. This will allow surgeons to increase efficiency during occipital-cervical-thoracic fusion procedures and work through challenging patient anatomies, Zimmer adds.
Virage is comprised of a variety of rods, anchors, transverse connectors, screws and polyaxial screws, which allow for case-by-case construction of implants. The screws enable a 112-degree range of motion and hold the rod in its desired place during implantation. The system also includes the necessary instruments for inserting and securing the implants, the devicemaker says.
A full-scale launch will begin in the third quarter of this year, Zimmer spokeswoman Joan Will told Device Daily Bulletin. The company next plans to pursue a CE mark for the device in Europe, followed by approval in other international markets in 2015, Will said. — Kellen Owings
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