BRYAN® CERVICAL DISC SYSTEM FACT SHEET


- Natural discs between each of the 24 bones (vertebrae) of the spine, act as flexible points allowing the spine to undergo a range of motion. They also provide some shock absorption for loads transmitted through the spinal column.

- Disc degeneration, which results as people age, and injury can both lead to herniation (commonly called a ruptured disc). Herniation describes a condition in which a portion of the disc bulges out between two vertebrae and irritates the spinal cord or nerves. A second form of degeneration, spondylotic growth (commonly called bone spurs) can also irritate the spinal cord and nerves.

- People with cervical disc herniation or spondylotic growth may have one or more of the following symptoms: neck pain, radiating arm pain, and temporary changes in nerve function that can result in tingling, numbness, or weakness in an arm or hand.

- Treatment generally begins with conservative methods, including physical therapy, anti-inflammatory medications, and pain relievers. Surgery is only recommended after non-surgical therapies have failed.

- Currently the most common form of surgery for treating degenerative disc disease in the neck is cervical disc removal followed by fusion. In this operation, the cervical spine is accessed through an incision in the anterior (front) of the neck, and the injured disc is removed. Following removal, the disc is replaced with bone from the patient’s hip or a bone bank, or with a metallic tube. In instances where the disc space is filled with bone, the area may then be reinforced with a metal plate attached with screws to the spinal vertebrae. Each of these alternatives is designed to produce a solid fusion between the vertebrae above and below the removed disc.

- Following anterior cervical fusion surgery, patients’ symptoms are relieved, but the fused vertebrae can limit neck movement and may put additional stress on the discs above and below the fusion.

- The BRYAN® Cervical Disc System features a prosthesis that is implanted in the neck. The device is designed to maintain the surgical benefits of an anterior approach to the spine including the symptomatic relief associated with the surgical decompression. However, unlike fusion, the damaged disc is replaced with the prosthesis, which is designed to allow for motion at the treated level. The implant incorporates an elastic nucleus to theoretically provide shock absorption similar to the natural disc.

- The BRYAN® Cervical Disc prosthesis consists of a polyurethane core that articulates between two titanium alloy shells. The disc interior is surrounded by a flexible polyurethane membrane that attaches to the shells.

- Clinical evaluation of the device under an Investigational Device Exemption (IDE) regulated by the U.S. Food and Drug Administration began in May 2002. The BRYAN® disc received the CE Mark in September 2000. Medtronic (MDT) has distributed the BRYAN® disc in more than 17 countries outside the U.S., where more than 2,000 patients have received the device.

- The first U.S. patient to receive the BRYAN® disc suffered from a herniated cervical disc after an automobile accident six months previous. After the accident, the patient experienced severely limited neck movement and acute left arm pain, which affected normal daily activities. Pain management therapies did not relieve the pain. Following the surgery, the patient is reported to have relief from the severe arm pain and is once again able to move his neck without pain.

- The BRYAN® Cervical Disc System, developed by American neurosurgeon Vincent Bryan, is available through Medtronic Sofamor Danek outside the United States. Medtronic acquired the BRYAN® disc and its parent company, Spinal Dynamics Corporation, on October 11, 2002.

- Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Medtronic Sofamor Danek USA, Inc., headquartered in Memphis, develops and manufactures products that treat a variety of disorders of the cranium and spine, including traumatically induced conditions, degenerative conditions, deformities, and tumors. More company information can be found at www.medtronic.com and www.medtronicsofamordanek.com.