Novel Approach to Vertebral Augmentation Procedures

The system features a flexible implant made from PEEK-OPTIMA, a biocompatible polymer that is widely used and well accepted as a spinal implant. The implant is delivered over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single, percutaneous incision. The amount of the Kiva implant delivered is physician-customized during the procedure.

Both right and left systems are available to enable access to the vertebral body from either pedicle, facilitating directional cement delivery and precluding posterior flow. Design features of the system includes a self-contained deployment handle that requires no preparation; and a nitinol coil (guidewire) that allows for controlled placement within the fractured region of the vertebral body and ensures accurate positioning of the Kiva Implant. The radiopaque implant can be adapted to various fracture morphologies. The Kiva System is a product of Benvenue Medical (Santa Clara, CA, USA).

The Kiva VCF Treatment is intended to be used in combination with the Benvenue Vertebral Augmentation cement kit, which contains highly visible polymethyl methacrylate (PMMA) bone cement and an easy-to-use injection system. The vertebral augmentation kit is designed to simplify the mixing and transferring of the PMMA bone cement with minimal exposure to fumes and to provide precise, controlled delivery of the bone cement, thus maximizing working time and facilitating visualization under fluoroscopy.

“We are excited to bring the Kiva System and its clinical benefits to the large and growing population of VCF patients in the US market,” said Robert Weigle, CEO of Benvenue Medical. “The VCF segment has little Level I clinical data, and we are proud to have sponsored one of the largest randomized studies in this space to date.”

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Benvenue Medical