FDA Nod for CareFusion’s AVAflex Vertebral Balloon System

San Diego-based medical technology company CareFusion announced that it has received a clearance from the US Food and Drug Administration for its AVAflex Vertebral Balloon System that can be used in kyphoplasty procedures on vertebral compression fractures through a single vertebral cannula. The technique provides a minimally invasive solution to treating vertebral compression fractures and combines AVAflex Curved Vertebral Augmentation Needle and the AVAmax Vertebral Balloon that allows targeted balloon placement along the midline of the vertebral body, thereby leading to targeted cement placement for optimal fill through a single pedicle.

Experts in the field have given their backing to the device, highlighting the increased safety approach for the patient. “The unipedicular approach offers a less risky approach to the midline of a vertebral body. Having another tool that places the cavity in the desired location can improve the effectiveness of vertebral augmentation in less time and with less radiation”, Montefiore Medical Center’s Dr Allan Brook said.



Source-Medindia