CareFusion announced the FDA 510(k) clearances for its 13-gauge AVAmax vertebral balloon system and its 11-gauge AVAmax vertebral balloon system.
The new 13-gauge system has a balloon that fits down a 13-gauge cannula, which has a cross-sectional area 37% smaller than the 11-gauge cannula and 50% smaller than the 10-gauge cannula. The new system expands the company’s devices that treat vertebral compression fractures, according to a company press release.
The new 11-gauge system enables targeted balloon placement across the midline of the vertebral body through a unipedicular, lateral approach, but higher in the spine through a smaller cannula. The system’s needle then allows targeted cement placement for an optimal fill. The 11-gauge AVAflex will be available in 15-mm, 20-mm and 30-mm lengths.
The company expects a full commercial launch within 1 year.