Vertebral Balloon System Enables Targeted Placement

A minimally invasive vertebral augmentation system treats vertebral compression fractures (VCFs), while also promoting patient safety.

The AVAflex Vertebral Balloon System combines a curved vertebral augmentation needle and a vertebral balloon to enable targeted balloon placement across the midline of the vertebral body, followed by targeted cement placement for optimal fill, all through a single pedicle. The curved needle is made from nitinol, a superelastic composite made of nickel and titanium. The ultraflexible qualities of nitinol allow the curved augmentation needle to target hard to reach areas in the vertebral body, allowing maneuverability and flexibility in creating a cavity in the vertebral body prior to balloon insertion.

The AVAmax vertebral balloon, in turn, allows the surgeon to perform kyphoplasty in areas where a larger balloon might prohibit the procedure. Each catheter contains a durable balloon filled with a contrast agent to aid visualization when creating a void in the vertebral body, as well as clearly defined marker bands on the shaft to help identify correct advancement and placement. A digital pressure monitor at the tip of the inflation syringe helps to monitor pressure levels. At the touch of a button, balloon pressure can be shown in either atmospheres or PSI.

An important feature of the system is that it allows bilateral fracture reduction using a unilateral pediclular approach. Access kits and inflation syringes are packaged single and sterile, minimizing waste and improving operational efficiency. The AVAflex Vertebral Balloon System is a product of CareFusion (San Diego, CA, USA), and has been approved by the US Food and Drug Administration (FDA).

“The unipedicular approach offers a less risky approach to the midline of a vertebral body,” said Allan Brook, MD, an interventional radiologist with Montefiore Medical Center (New York, NY, USA). “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.”

Kyphoplasty uses a two-step process of inserting of a balloon device into the compacted vertebrae to attempt to restore the vertebrae to a more normal shape. Subsequently, a cement-like material is injected into the space created by the balloon to retain the correction. By restoring the vertebrae to a more normal state, alignment of the spine may be improved.

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