The PEEK implant delivers structural support to avoid the further collapse of the vertebral body
IZI Medical Products has secured CE mark approval for its Kiva vertebral compression fracture (VCF) treatment system.
Kiva, a unipedicular PEEK implant-based treatment solution for VCFs, has achieved clinical and commercial success in the US, said the company.
IZI Medical CEO Greg Groenke said: “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.”
The Kiva System has demonstrated to reduce the rate of adjacent level fractures
The Kiva System has demonstrated to minimise reduce the rate of adjacent level fractures, reduce the rate of cement extravasation, and offer kyphotic angle restoration in two level I clinical studies.
The PEEK implant is said to mimic cancellous bone and offer structural support that avoids the further collapse of the vertebral body.
IZI Medical’s new system uses an advanced unipedicular deployment method to enable midline placement and support the axial vertebral body load.
The National and Kapodistrian University of Athens’s radiology and interventional radiology professor Dr Alexis Kelekis said: “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.”
IZI Medical Products is engaged in the development, manufacturing and distribution of medical consumable devices used in interventional radiology and oncology, radiation therapy, neuro-spine, and image-guided surgery procedures.
The company currently markets its products to over 1,000 domestic customers, as well as globally across 25 countries.
In July this year, Cerus Endovascular secured CE mark approval for its advanced CerusEndo MC 021 microcatheter to market in the European Union region.