Interventional radiology device maker Izi Medical Products (Owings Mills, Md.) announced today that it has received the CE mark for its Kiva vertebral compression fracture (VCF) treatment system.
Kiva is a unipedicular PEEK implant-based treatment system that is already available in the U.S. The implant is designed to mimic cancellous bone and provide structural support to prevent further collapse of vertebral body. Its unipedicular deployment method allows midline placement to support the axial vertebral body load.
In two Level I clinical studies, the Kiva system was shown to reduce the rate of adjacent level fractures, reduce the rate of cement extravasation, and provide kyphotic angle restoration, according to the company.
“We are excited to provide this novel implant technology to the European market and have made significant investments in our international distribution network to broaden our VCF offering,” said Izi Medical CEO Greg Groenke in a news release.
“Kiva is the ideal augmentation device when cortical bone damage is involved because cement containment is very critical in those cases, especially in VCFs due to tumor or trauma,” added Dr. Alexis Kelekis, professor of Radiology and Interventional Radiology, National and Kapodistrian University of Athens. “It is perfect to fill the void left post-ablation when treating metastatic VCFs as it prevents further collapse. Physicians like the Kiva PEEK implant as it provides additional structural stability. We can avoid increased volumes of cement and its inherent risks, one of which is extravasation, with a great biomechanical result leading to long-term clinical benefit.”