CareFusion, a San Diego-based medical technology corporation, received FDA 510(k) clearance for two of its spine augmentation devices.
Here are four things to know:
1. The 13-guage AVAmax Vertebral Balloon system is designed for vertebral compression fractures. The device's small cannula size avoids more trauma than larger cannulas.
2. It is the smallest straight-line vertebral balloon available, offering vertebral augmentation higher in the spine than other products.
3. The 11-guage AVAflex Vertebral Balloon system offers targeted balloon placement across the midline of the vertebral body through a unipedicular, lateral approach. The device's needle allows pointed cement placement for an ideal fill.
4. CareFusion plans to commercially launch the two devices within a year.