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Reimbursement / Regulatory

CareFusion Receives 510(k) Clearances for 2 Spine Augmentation Products -

CareFusion announced FDA 510(k) clearance for two of its spine augmentation devices.

The first, the 13-gauge AVAmax® Vertebral Balloon system, will treat vertebral compression fractures by fitting down a 13-gauge cannula, with a cross-sectional area 37 percent smaller than the 11-gauge cannula and 50 percent smaller than the 10-gauge cannula. The AVAmax will be offered in 10mm, 15mm and 20mm lengths and will reportedly be the smallest straight-line vertebral balloon on the market.

The second device is the 11-gauge AVAflex® Vertebral Balloon System, which will enable targeted balloon placement across the midline of the vertebral body through a unipedicular and lateral approach, higher in the spine through a smaller cannula. The AVAflex will be available in 15mm, 20mm and 30mm lengths and will reportedly be the smallest curved balloon in the industry.

CareFusion expects full commercial launch within one year.

These products will add to the company’s existing portfolio of vertebral balloon products, such as the 11-gauge AVAmax® vertebral balloon.

Source: CareFusion

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