Benvenue Medical Inc. says its Kiva system has gained 510(k) clearance, making it the first new approach for the treatment of vertebral compression fractures in over a decade. Kiva is an implant-based solution for vertebral augmentation, an alternative to balloon kyphoplasty. The PEEK-OPTIMA polymer implant is deployed with a specialized guidewire into the vertebral body, and is designed to provide structural support and to contain and direct the flow of polymethyl methacrylate (PMMA) bone cement. The goal is to reduce the amount of necessary PMMA, also used for kyphoplasty, and replace it with an implant that has more flexibility, closer to native bone. (See Also see "Benvenue Medical Touts Next-Generation Treatment For Vertebral Compression Fractures" - Medtech Insight, 28 October, 2013..)
Benvenue says its randomized study data shows Kiva met or exceeded the performance of Medtronic PLC’s Kyphon kyphoplasty system. The firm completed enrollment in its 300-patient KAST study comparing...
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