Voting 5 to 1, an advisory panel for the U. S. Food and Drug Administration (FDA) has failed to recommend Zimmer Holdings Inc.'s Dynesys, a back-support device, due to inadequate information relating to the device's safety and effectiveness. Though, it generally does, FDA is not bound to follow any advice given by the panel.

According to Mark Melkerson, FDA's Director of Surgical and Restorative Devices Division, Zimmer failed to provide adequate information regarding the product, including not following up with patients implanted with the device to determine whether or not the product worked for them.

FDA believes the device is as safe as any other product for providing back support, however, there is no supporting evidence about the long-term effectiveness of the device. Spinal systems are implanted in patients for life, which means they could break down over time, making durability an important factor.

Indiana-based Zimmer is seeking FDA approval for using the Dynesys Spinal System in patients experiencing moderate pain, the outcome of spinal problems. Already, the device is being used for helping stabilize spines in spinal fusion surgery patients, and if approved, it will be the first product to be given approval for non-fusion use in the U. S. A.

The device was studied in over 300-patients suffering from nerve damage and spinal stenosis i. e. a narrowing of the back that can result in severe back and leg pain.

In addition, FDA is questioning payments made to investigators, as Zimmer submitting financial information to the FDA as part of routine disclosures admits to paying over $500,000 to certain Dynesys testing locations.