Clinical Trials Open for New Treatment of Degenerative Disc Disease

New York, NY—February 17, 2004

Hospital for Special Surgery (HSS) in Manhattan is now conducting a clinical trial on the usage of MAVERICK™, an artificial lumbar (back) disc for the treatment of Degenerative Disc Disease (DDD), a condition of the spine that is characterized by pain in the lower back, which radiates down to the buttocks and lower legs. The artificial disc clinical trial will help support an application to the U.S. Food and Drug Administration (FDA) that could allow the approved future use of this device.

According to Dr. Harvinder Sandhu, Attending Spine Surgeon at HSS and Principal Investigator at the hospital, "At least 200,000 lumbar surgeries are performed in the United States every year to treat degenerative disc disease. These surgeries usually entail a fusion often with the use of instrumentation such as rods, screws, and cages. The MAVERICK™ Artificial Disc could potentially offer another option to these patients that may better restore function of the lumbar spine. The disc's design is based on decades of total joint replacement experience."

What is Degenerative Disc Disease
Degenerative disc disease (DDD) is part of the natural process of growing older. As people age, their discs lose their flexibility, elasticity, and shock absorbing characteristics. Discs are gel-like cushions that act as shock absorbers between each of the bones of the spine. For approximately half of the over 40 population, this process can cause several different symptoms, including back pain, nerve root pathology, and spinal cord compression. These symptoms are caused by the fact that worn out discs are a source of pain because they do not function as well as they once did, and as they shrink, the space available for the nerve roots and the spinal cord also shrinks.

Who is eligible for this clinical trial
The ideal candidate for this trial is a skeletally mature adult between 18 - 70 years of age, diagnosed with degenerative disc disease who has not responded to non-operative treatment for a period of 6 months

Traditional Spinal Fusion vs. MAVERICK™
Spinal fusion surgery involves the joining or fusing of one or more vertebrae to reduce pain and stabilize the spine. Traditionally, spinal fusion requires the transplant of bone chips from a patient's pelvis to the spinal vertebrae (column) to help "fuse" them together. Although this procedure can be very effective for the treatment of certain spinal disorders, the bone transplantation procedure (bone grafting) can prolong surgery, increase blood loss, increase hospital stay, increase recovery time, and increase recovery pain. Nearly 40% of patients who have had bone grafting, experience some discomfort even two years after surgery. Moreover, the bone grafting technique does not always reliably result in successful fusion of the vertebrae because of occasional inadequate bone growth.

MAVERICK™ is a metal on metal designed disc that is inserted into the spine through the abdomen. It eliminates the need for fusing the vertebrae together. In fact, immediately after surgery, the disc replacement allows improved motion between the vertebrae.

Purpose of the Clinical Trial
The purpose of this clinical trial is to compare the outcomes of patients who receive an artificial disc with those of patients who have a lumbar fusion. Patients who enroll in the clinical study will be randomly assigned a treatment group. Approximately two-thirds of the patients will receive the MAVERICK™ Artificial Disc and one-third of the patients will receive the control treatment. Medtronics Sofamor Danek is the sponsor of this trial.

How to enroll
If you are interested in being considered a candidate for the MAVERICK™ Artificial Disc clinical trial, please call 212-606-1798 to find out if you are a potential candidate. Or, for more information on the clinical trail or lumbar (back) disorders, please go to http://www.back.com/clinicaltrial/.