Carefusion received FDA clearance for its AVAflex Vertebral Balloon System, a device that allows to perform kyphoplasty procedures on vertebral compression fractures through a single vertebral cannula.
Typically, two pedicles of the vertebra have to be penetrated in order to deliver the balloon and subsequent bone cement injection. Being able to perform the same task through one cannula will hopefully have significant benefit for patients, as well as help make the procedure faster and easier to complete.
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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 AVAflex Vertebral Balloon System is in limited commercial release in multiple hospitals across the U.S.
“The ability to steer a balloon through a unipedicular approach cannot be overstated in its simplicity and efficiency,” said Dr. Michael Verdolin of Verdolin Pain Specialists in Chula Vista, Calif. after using the product. “The procedure was faster, with less patient discomfort.”
Dr. Allan Brook, an interventional radiologist with Montefiore Medical Center in Bronx, N.Y. and the first physician to use the new device on the East Coast, said “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.”
Another physician using the device in limited commercial release, Dr. Langham Gleason, a neurosurgeon with the South Texas Brain and Spine Center in Corpus Christi, Texas, said “The AVAflex Vertebral Balloon System works extremely well to allow bilateral fracture reduction using a unilateral approach. I suspect that placement of bilateral vertebral cannulas will largely fade away in the future.”
Press release: CAREFUSION RECEIVES 510(k) CLEARANCE FOR VERTEBRAL AUGMENTATION SYSTEM…
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