CareFusion receives FDA clearance for 2 spine devices: 4 things to know

CareFusion, a San Diego-based medical technology corporation, received FDA 510(k) clearance for two of its spine augmentation devices.

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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.

 

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