Jacksonville, Florida, September xx, 2006 Neurosurgeons with Lyerly Neurosurgery, an affiliate of Baptist Health, are the first physicians in Florida to be approved to study the NeoDisc artificial cervical disc replacement device in a national investigational device exemption (IDE) study. Javier Garcia-Bengochea, MD, will serve as principal investigator for the IDE study in Jacksonville, and fellow neurosurgeons Paulo Monteiro, MD, and Andrew Cannestra, MD, PhD, will join him in the study.

There are currently no FDA-approved artificial cervical discs on the market, but there are a number of the devices currently being developed and studied. While other discs are generally metal-on-metal or metal-on-plastic, the NeoDisc designwhich is owned by NuVasive^®, Inc. in San Diego, California -- is the only one made entirely of polymer, with a compliant elastomeric core encased in a polyester textile jacket.

Garcia-Bengochea, who has designed a number of implants and procedures for minimally invasive spine surgery, said the design of the NeoDisc device is novel. "It allows the disc to function as a shock absorber in the spine, in addition to providing motion, as opposed to current disc designs that function more as moveable joints with no shock-absorbing capacity," he says. "The NeoDisc also reconstructs an important ligament on the front of the spine, which is not possible with other current disc replacement devices."

Eligible patients for the study will be between the ages of 18 and 60; they would otherwise receive a single-level anterior cervical discectomy and fusion, a motion- restricting operation that is performed on the upper spine to relieve pressure on one or more nerve roots, or on the spinal cord. This surgery involves removing the ruptured disc through a small incision in the neck and fusing the space with a small piece of bone or bone substitute, followed by placement of a plate to stabilize the spine. Patients who have had a previous discectomy and fusion and have a new problem in the neck may also be eligible for the study.

"The issue with this surgery has been what is termed 'adjacent segment disease' that results after fusion surgery," explains Garcia-Bengochea. "When a disc is fused by a surgeon or as a result of the arthritis process, the joints above and below the fused area naturally receive more stress. The notion is, if you can replace the disc with a moving part such as an artificial disc, you might lessen the stresses and, subsequently, the breakdown of discs above and below the fusion.

"The artificial disc replacement device will not entirely replace the very successful fusion procedure, but we hope that the advent of artificial discs in the neck will be an alternative treatment in selected patients which will preserve motion and lessen the incidence of adjacent segment disease. This will mean a more productive and higher quality of life for patients, and reduce the likelihood of multiple fusion surgeries in the future."

"Participating in this study and other clinical trials is all about improving treatment by offering more options and more choices for patients," says Cannestra. "For patients in Northeast Florida, this is the first opportunity to be involved in a cervical disc replacement study that could enhance their quality of life."

For more information about the study, please call Study Coordinator Barbara Hurlbert, CMPE, at 904.388.6518.

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