Benvenue Medical has reported that over 250 patients have been enrolled in its Kiva system as a vertebral augmentation treatment - a safety and effectiveness trial (KAST).
The controlled, non-inferiority, randomized, investigational device exemption (IDE) trial is designed to compare Kiva to balloon, which is the current standard of care in vertebral compression fractures (VCF) treatment.
Benvenue Medical CEO Robert Weigle said the company believes the progress it is making with KAST is a result of the spine community’s desire to examine and validate the potential benefits of the Kiva system which potentially includes cement containment, a reduced cement volume while utilizing a minimally invasive, unipedicular approach.
Kiva system features a proprietary flexible implant made from Peek-optima and is designed to function as a mechanical support structure and a reservoir to contain and direct the flow of bone cement.
The implant is delivered percutaneously in a continuous loop fashion into the vertebral body with an all-in-one disposable device through a small diameter, single incision to provide structural support to the vertebral body and to directionally control and contain bone cement.