Procedure

Kivaplasty^™, a minimally invasive technique with the Kiva VCF Treatment System to treat VCFs, utilizes a unilateral, transpedicular approach to access the vertebral body. The Kiva VCF Treatment System, containing the Kiva Coil and Kiva Implant, is introduced via a working cannula through a 5 mm incision.

The Kiva Coil is advanced to create a path through the cancellous bone and provide a guide for the Kiva Implant. Kivaplasty preserves the structure of the cancellous bone facilitating interdigitation of PMMA between the Implant and the native bone.

The Kiva Implant forms a stacked, cylindrical column centered at the midline of the vertebral body. Reduction of the compression fracture is achieved via height distraction of the vertebral body. The amount of Implant deployed may be adjusted by the physician to adapt to various fracture morphologies. 

PMMA bone cement is injected through the lumen of the Kiva Implant, which helps to contain and control the distribution of the cement.  Once cured, the cement interlocks the Implant to the cancellous bone. With proper symmetric placement in the midline of the vertebrae, the Kiva Implant and PMMA construct provide bilateral fracture support through a single access. 

Europe — The Kiva VCF Treatment System and the Benvenue Medical Vertebral Augmentation Cement Kit bear the CE mark and are available for sale in Europe.  The Kiva VCF Treatment System is indicated for the reduction and treatment of pathological compression fractures of the thoracic and lumbar spine that may result from osteoporosis, benign lesions and/or malignant lesions. This is to be offered only when traditional medical therapy has not provided pain relief and pain is substantially altering the patient’s lifestyle. It is intended to be used with Benvenue Medical Vertebral Augmentation Cement Kit.

United States - CAUTION - Investigational device. Limited by United States Federal Law to investigational use

Under the KAST study, the Kiva VCF Treatment System is being evaluated for the reduction and treatment of painful pathological compression fractures of the thoracic and lumbar spine that may result from osteoporosis. It is intended to be used with Benvenue Medical Vertebral Augmentation Cement Kit.

Canada — Investigational Device. To be used by Qualified Investigators only. Instrument de Recherche. Réservé uniquement à l’usage de chercheurs competent.