The Kiva VCF Treatment System by Santa Clara, Calif.-based Benvenue Medical has received FDA 510(k) clearance for the treatment of spinal fractures. The Kiva system is an implant-based treatment for vertebral augmentation and an alternative to balloon kyphoplasty. The cylindrical implant is made of PEEK-OPTIMA material.
The results of the Kiva safety and effectiveness trial will be presented at the upcoming Society for Interventional Radiology meeting in March.
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