AthroCare Receives FDA Clearance For A New Device To Treat Spinal Fractures

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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. According to Dr. Eren Erdem from the radiology and neurosurgery department at the University of Arkansas for Medical Sciences, about 20 to 30 percent of multiple myeloma patients undergo a surgical procedure.

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.

“Cavity creation with mechanical devices [such as the Contour device] has the advantage of not destructing the bone that happens with a balloon, but creating channels of less resistance for cement to follow and decreasing the chance of [cement leakage],” explained Dr. Erdem.

“The Contour system is a good system with a small cavity creater followed by injection of a viscous cement,” said Dr. Erdem. “However, to our experience, there is a better system made by the company Dfine called RF Kyphoplasty.”

“The [Dfine] cavity creater is more robust and allows cavity creation not only in the center of the bone but more site-specific and size-specific,” explained Dr. Erdem. “The cement that comes in this system has the highest viscosity in the market and stays the same for 30 minutes. This is very important in multiple myeloma with lytic areas and higher incidence of leakage and complications.”

Another procedure has been designed to reduce the risk of cement leakage. During this new procedure, known as vesselplasty, a small bag is placed inside the vertebra before the addition of the bone cement.

Height restoration is another important aspect of these surgeries. According to Dr. Erdem, full height restoration is rarely achieved. In his opinion, balloon kyphoplasty and the Dfine system currently provide the best height restoration, but vesselplasty also has significant potential.

For more information, please see the ArthroCare press release.

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