Vertebral Augmentation System

The Kiva System is a revolutionary implant-based solution for vertebral augmentation, offering an alternative to balloon kyphoplasty and providing the first new approach to treating vertebral compression fractures (VCFs) in over a decade. Developed by IZI Medical Products, LLC from United States, the Kiva System has been studied extensively and proven to meet or exceed the performance of balloon kyphoplasty in Level I/II clinical studies.

What Is The Kiva System?

The Kiva System is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5*. It consists of two kits - the Kiva VCF Treatment System, Right, First Fracture Kit (KIV2100) and the Kiva VCF Treatment System, Left, First Fracture Kit (KIV2200). Accessories a la Carte include the Kiva Pilot, Right (PLT2100), Kiva Pilot, Left (PLT2200), Kiva Bone Drill (ACC5225), Kiva Ultraflex Cement Needle Kit (ACC5350), and Kiva Introducer Set (ACC5270). Additionally, cement and mixers such as Osteo-site VCF Kit (w/ Vertefix Cement) (G80003), Osteo-site Mixing and Injection System (G80000), and Vertefix Cement (G90002) are also included.

How Does The Kiva System Work?

The Kiva System allows physicians to deliver an implant with a predictable structure through a transpedicular approach. This implant functions as a reservoir to contain and direct the flow of cement. When combined with the IZI Vertebral Augmentation Cement Kit, it provides a safe and effective way to reduce and treat spinal fractures.

Clinical Evidence Supporting The Kiva System

The Kiva System has been studied extensively in various clinical trials, including the KAST Study: The Kiva System As a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial, KIVA VCF system in the treatment of T12 osteoporotic vertebral compression fracture, Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data, Is Kiva Implant Advantageous to Balloon Kyphoplasty in Treating Osteolytic Metastasis to the Spine? Comparison of 2 Percutaneous Minimal Invasive Spine Techniques, Percutaneous Vertebral Augmentation Assisted by PEEK Implant in Painful Osteolytic Vertebral Metastasis Involving the Vertebral Wall: Experience on 40 Patients, Is Kiva Implant Advantageous to Balloon Kyphoplasty in Treating Osteolytic Metastasis to the Spine? Comparison of 2 Percutaneous Minimal Invasive Spine Techniques, Transpedicular vertebral body augmentation reinforced with pedicle screw fixation in fresh traumatic A2 and A3 lumbar fractures: comparison between two devices and two bone cements, Percutaneous Vertebral Augmentation Assisted by PEEK Implant in Painful Osteolytic Vertebral Metastasis Involving the Vertebral Wall: Experience on 40 Patients, Balloon Kyphoplasty Versus KIVA Vertebral Augmentation—Comparison of 2 Techniques for Osteoporotic Vertebral Body Fractures, Kiva® VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures, Comparison of Balloon Kyphoplasty with the New Kiva® VCF System for the Treatment of Vertebral Compression Fractures, Percutaneous vertebral augmentation for painful osteolytic vertebral metastasis: a case report, An Overview. All these studies have demonstrated that the Kiva System can provide a safe and effective way to reduce and treat spinal fractures.

Conclusion

The Kiva System developed by IZI Medical Products, LLC offers a novel approach to the treatment of vertebral compression fractures. Through extensive clinical research, it has been shown to meet or exceed the performance of balloon kyphoplasty and provide a safe and effective way to reduce and treat spinal fractures. Healthcare distributors looking for a reliable and innovative vertebral augmentation system should consider the Kiva System.