US-based interventional radiology devices manufacturer IZI Medical Products has received CE Mark approval in Europe for the Kiva Vertebral Compression Fracture (VCF) Treatment System.
Kiva is a unipedicular PEEK implant-based treatment solution for VCFs.
The PEEK implant is designed to act like a cancellous bone and offers structural support to prevent the vertebral body from further collapses. The unipedicular deployment method of the implant enables midline placement, which supports the axial vertebral body load.
Furthermore, Kiva system is an ideal augmentation device for cases, in which cortical bone damage is involved, especially in VCFs due to trauma or tumour.
The system also prevents further collapses when treating metastatic VCFs and is suitable for filling the void left post-ablation.
Kiva System was shown to reduce the rate of adjacent level fractures and cement extravasation in two Level I clinical studies. It was also found to offer kyphotic angle restoration in the studies.
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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 company noted that Kiva VCF treatment system has seen both clinical and commercial success in the US.
IZI Medical develops, manufactures and distributes medical consumable accessories used in radiology, radiation therapy, neuro-spine and image-guided surgery procedures.
Last month, the company launched its Osteo-Site Vertebral Balloon for vertebral augmentation as part of its VCF portfolio.
In 2011, Landauer acquired all outstanding equity interests of IZI Medical Products for approximately $93m.