Benevue Medical gets FDA clearance for KIVA, the first new VCF system since Kyphon

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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 ...

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