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Kiva® VCF Treatment System

Treatment of Vertebral Compression Fractures

Vertebral compression fractures (VCFs) occur when a vertebra (bone in the spine) cracks, fractures or collapses. Patients who have vertebral compression fractures can suffer severe and disabling pain and if left untreated, can experience impaired function and decreased activity.

VCFs remain underdiagnosed and undertreated. The National Osteoporosis Foundation estimates that there are 750,000 osteoporosis-related vertebral compression fractures annually in the U.S. alone, representing a large patient population which is only expected to continue growing as the population ages.

Without intervention, the pain from a VCF may subside as the fracture heals, and the vertebra heals in its deformed, compressed position. This shortened, compressed vertebra alters the normal alignment of the spine, putting the spine at greater risk for subsequent level fractures.

Surgical Treatment Using the Kiva® CVF Treatmnet System

Surgical treatment for VCF includes vertebroplasty, balloon kyphoplasty and a new treatment option using the Kiva® VCF Treatment System. The Medical Center is the first hospital in Kentucky to utilize the Kiva System that has been shown to reduce pain and restore function and improve long-term results by reducing future fractures.

The Kiva System by Benvenue Medical, Inc. is the first new, clinically proven approach to the treatment of VCFs in more than a decade. The Kiva System received 510(k) clearance from the U.S. Food and Drug Administration for the reduction and treatment of spinal fractures in January 2014.

In clinical studies, the Kiva System was shown to match the performance of balloon kyphoplasty. Kiva has also been demonstrated to reduce the rate of adjacent level fractures, improve restoration of the curvature of the spine, reduce the rate of cement leakage into surrounding tissue and reduce the amount of cement used.

Used during a minimally invasive procedure, the Kiva implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. Once the implant is in position, bone cement is introduced through the implant to stabilize the fracture. The amount of the Kiva Implant delivered is physician-customized during the procedure.


Once the Kiva implant is positioned in the center of the vertebra, bone cement is introduced through the implant to stabilize the fracture.

 

The Kiva Implant is made of medical grade plastic called PEEK-OPTIMA®, which is closer to the consistency of natural bone than bone cement, which is significantly harder. PEEK-OPTIMA is a biocompatible polymer that is widely used and well accepted as a spinal implant.