ArthroCare Corp. has received clearance from the U.S. Food and Drug Administration to market its Parallax Contour Vertebral Augmentation Device. The Contour device can now be used during minimally invasive surgical procedures to treat spinal fractures caused by multiple myeloma bone lesions.

Weakening of the vertebrae, the bones that make up the spine, can result in vertebral compression fractures. Though the most common cause of vertebral compression fractures is osteoporosis, they may also be caused by multiple myeloma tumors.

Patients with vertebral compression fractures often suffer from debilitating pain and may experience changes in their height. Non-surgical treatments for vertebral fractures include radiation, pain medication, short periods of bed rest, calcium and vitamin D supplementation, as well as the use of external back braces. Patients whose compression fractures do not respond to medical treatment can undergo surgical procedures to treat their fractures.

ArthroCare’s Contour device uses a movable, curved needle to displace soft bone, creating a space into which bone cement can be delivered to stabilize the fracture. It is used with vertebroplasty or kyphoplasty procedures, in which physicians use image guidance to inject bone cement through a hollow needle into the fractured bone.

The Contour device would most likely be used as an alternative to balloon kyphoplasty, in which an inflatable balloon is inserted through a needle into the fractured bone, creating a space for bone cement to be delivered after removal of the balloon.

Leakage of the cement out of the vertebrae is a potential complication of these procedures. In a new procedure, known as vesselplasty, a small bag is placed inside the vertebra before the addition of the bone cement to reduce the risk of cement leakage.

For more information, please see the ArthroCare press release.