FDA CLEARANCE FOR KIVA VCF SYSTEM (Orthopedics This Week)
The Kiva VCF Treatment System is for the reduction and treatment of VCFs (vertebral compression fractures) of the spine. According to the company announcement on January 28, 2014, the clearance makes the Kiva the first new approach to the treatment of VCFs in over a decade. Also, according to the company, in the clinical studies provided for the 510(k) application, the system was shown to meet or exceed the performance of balloon kyphoplasty.
The implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered is physician-customized during the procedure.
Sean M. Tutton, M.D., FSIR, and co-principal investigator in the KAST Study (Kiva System as a Vertebral Augmentation Treatment – Safety and Effectiveness Trial), which compared Kiva to the Medtronic KyphX System for balloon kyphoplasty, said he looks forward to presenting the results at the Soci...
