|Dynesys Spinal System|
Chronic back and leg pain in the lumbar region, caused by problems with the intervertebral discs, are usually treated non-invasively for as long as possible. When such treatment no longer provides relief, the primary solution until now has included removal of the affected discs and fusion of the vertebral segments. It is estimated that nearly 400,000 people in the U.S. undergo spinal fusion procedures each year.
The first Dynesys device was implanted in Europe in 1994 and has treated over 9,000 patients. The Dynesys Spinal System has recently been approved for clinical trials at only 20 spine centers in the United States, including the Spine Institute of New York. This procedure may provide an alternative to patients suffering from spondylolisthesis and spinal stenosis, who previously would have needed spinal fusion surgery to moderate pain from compressed nerves.
The Spine Institute is one of the twenty hospitals enrolling patients into this FDA controlled clinical trial to assess the safety and effectiveness of the Dynesys Spinal System. This new treatment will be compared to the current standard treatment to see which is more successful.
The Dynesys system consists of external spacers made of surgical polyurethane (flexible plastic tubing) surrounding a polyethylene (nylon-like) cord. The device is attached to both sides of the vertebrae in the affected area of the spine, stabilizing the spine without fusing and preserving its natural curve, which allows the patient a greater degree of mobility, in addition to reducing the pain caused by excess motion.