CarboFix has announced that the US Food and Drug Administration (FDA) has cleared its CarboClear Carbon Fiber Vertebral Body Replacement (VBR) System to replace a collapsed, damaged, or unstable vertebral body due to tumour or trauma.
The CarboClear VBR System joins the FDA cleared CarboClear Pedicle Screw and CarboClear Fenestrated Pedicle Screw Systems.
The CarboClear VBR implant is made of carbon fibers, with integrated porous Ti-alloy endplates. Carbon fiber implants are proposing unique advantages to the oncological patients and their physicians. Among those advantages are: enhanced radiation therapy planning abilities, allowing radiation treatment to optimise the radiation dose to the tumoiur with minimal collateral tissue damage, and enhanced follow up abilities due to artifacts-free imaging.
In addition, the implants provide unparalleled fatigue strength to support the impaired healing process in those patients, as well as compatibility with particle radiation (proton and carbon ion) and other stereotactic radio-surgery modalities.