IZI Medical Products, LLC (“IZI”), a leading manufacturer of interventional radiology devices, announces that it has received CE Mark approval in Europe for the KivaTM Vertebral Compression Fracture (VCF) Treatment System. Kiva is a unipedicular PEEK implant-based treatment solution for VCFs that has seen clinical and commercial success in the US.
“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 Greg Groenke, Chief Executive Officer, IZI Medical.
“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. 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,” said Dr. Alexis Kelekis, Professor of Radiology and Interventional Radiology, National and Kapodistrian University of Athens.
In two Level I clinical studies, the Kiva System has shown to reduce rate of adjacent level fractures, reduce rate of cement extravasation, and provide kyphotic angle restoration. The PEEK implant mimics cancellous bone and provides structural support which prevents further collapse of vertebral body. Its unique unipedicular deployment method allows midline placement which supports the axial vertebral body load.
