WHAT ARE THE BENEFITS OF KIVA? The Kiva VCF Treatment System has been shown to reduce pain and restore function for patients with VCFs. Kiva has also demonstrated to meet or exceed the performance of balloon kyphoplasty in three separate comparative studies. In one or more of these studies1,2,3, as compared to balloon kyphoplasty, Kiva was shown to: • Reduce rate of adjacent level fractures • Improve kyphotic angle restoration • Reduce rate of cement extravasation • Reduce cement volume As with other vertebral augmentation devices and procedures, there are risks and considerations for use of Kiva. The risks include serious complications up to and including death. Please consult your physician for a more detailed discussion of risks, contraindications, warnings, precautions, and specific treatment options. REFERENCES: 1. KAST: The Kiva System as a Vertebral Augmentation Treatment - A Safety and Effectiveness Trial, Tutton, Garfin, et al. Spine, March 2015 2. Balloon Kyphoplasty versus Kiva Vertebral Augmentation. Comparison of Two Techniques for Osteoporotic Vertebral Body Fractures. A Prospective Randomized Study, Korovessis et al. Spine, February 2013 3. Comparison of Balloon Kyphoplasty with the New Kiva VCF System for the Treatment of Vertebral Compression Fractures, Otten, Pflugmacher, et al. Pain Physician Journal, October 2013 The Kiva VCF Treatment System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5. It is intended to be used with the IZI Vertebral Augmentation Cement Kit. <§>IZI Medical WWW.IZIMED.COM L122, Rev. B KivaVCF Treatment System Minimally Invasive Treatment For Vertebral Compression Fractures

KIVA VCF TREATMENT SYSTEM VERTEBRAL COMPRESSION FRACTURES (VCFS) A COIL IS ADVANCED TO CREATE A PATH THROUGH THE VERTEBRAL BODY BONE AND PROVIDE A PATHWAY FOR THE KIVA IMPLANT. Your physician may recommend that you be treated with Compression fractures of the spine occur when a vertebral augmentation using the Kiva VCF Treatment vertebra - the bones of the spinal column - cracks, System. Kiva features a flexible implant made from a fractures, or collapses. These spinal fractures are unique polymer material widely used in spinal implants. The because they frequently occur without apparent Kiva...