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CareFusion receives 510(k) clearance for vertebral balloon system

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The FDA has issued 510(k) clearance to CareFusion for its AVAflex Vertebral Balloon System.

According to a company press release, the AVAflex Vertebral Balloon System combines the unique features of the AVAflex Curved Vertebral Augmentation Needle and the AVAmax Vertebral Balloon to enable targeted balloon placement across the midline of the vertebral body, followed by targeted cement placement for optimal fill through a single pedicle. The focus of the AVAmax products is to provide a minimally invasive solution to treat vertebral compression fractures, while also promoting safety for the patient, physician and staff. CareFusion expects a full commercial launch of the AVAflex Vertebral Balloon System in this spring.