CareFusion wins dual FDA 510(k) for vertebral balloons

Becton Dickinson & Co. (NYSE:BDX) subsidiary CareFusion said today it won FDA 510(k) clearances for 2 sizes of vertebral balloon systems designed for spinal augmentations.

The company received clearance from the FDA for its 13-gauge AVAmax and 11-gauge AVAflex vertebral balloon systems for treating vertebral compression fractures.

“We are committed to investing in research and development to create new innovations that benefit patients and providers. We are proud to offer a wide variety of minimally invasive vertebral augmentation devices for providers to choose the right treatment for their patients,” BD V. Mueller and Interventional Specialties infection prevention GM Jim Leitl said in a press release.

The 13-gauge balloon has a smaller cross-sectional area than both the 11-gauge and 10-gauge cannulas, creating a smaller access point and less trauma than larger cannulas. Carefusion will offer the 13-gauge balloon in 10mm, 15mm and 20mm lengths.

The 11-gauge AVAflex allows for placement across the vertebral body midline through a unipedicular, lateral approach. The AVAflex comes with a needle that allows targeted cement placement. Carefusion said it will offer the 11-gauge in 15mm, 20mm and 30mm lengths.

CareFusion said it expects a full commercial launch within the year.

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