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. 

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