The Kiva VCF Treatment System has the CE mark of approval and has been used to treat more than 500 vertebral compression fractures globally. The system delivers the PEEK-OPTIMA implant percutaneously to stabilize and support the vertebral body. It also serves as a conduit for bone cement placement.
The system will be distributed in Germany and Italy, and the companies expect to broaden its availability in the near future. The system is also being evaluated in an IDE study comparing it with balloon kyphoplasty to support a potential FDA market clearance.
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