FDA Approval Expected for Lumbar Artificial Disc
IDE Study Results Show Patients Return to Active Life More Quickly
CHICAGO, IL—October 27, 2004—People who've suffered for years from the pain of degenerative and herniated discs now have an option that may relieve the pain, allow them quick recovery and enable them to lead active and productive lives. The Food and Drug Administration (FDA) approval of the Charité Artificial Disc is expected sometime within the month. The approval follows the recommendation of the FDA device panel back in June. The Chicago Institute of Neurosurgery and Neuroresearch (CINN) medical group was the only physician group in Chicago to participate in the investigational device exemption (IDE) study for this artificial disc. Results show that artificial disc patients have shorter hospital stays, less post-operative pain and they return to daily activities more quickly than those who have spinal fusion surgery.
The artificial disc is expected to impact more than 400,000 Americans who suffer from degenerative disc disease (DDD). "The overall results of the IDE study are compelling enough that people with degenerative disc disease in the low back should consider the option of an artificial disc," says Dr. Noam Stadlan, one of the few neurosurgeons in the country trained to implant the spinal device. "In addition to the benefit of less pain post-operatively and a faster recovery, the disc is unique in that it restores flexibility, unlike other available options that limit motion." Over the course of the three-year trial, CINN has implanted over 80 artificial discs, 60 of which were at The Neurologic & Orthopedic Hospital of Chicago, which specializes in breakthrough technology and minimally invasive techniques in neurosurgery and orthopedics. Once FDA approval is received, Dr. Stadlan will also perform the surgery at Elmhurst Memorial Hospital, Ingalls Memorial Hospital, Rush North Shore Medical Center and Rush University Medical Center.
To date, use of the artificial disc has been limited to patients between the ages of 18 to 60 who presented with lower back pain caused by a single level degenerative disc. Once FDA approval is received, however, trained surgeons will be able to use the device, when appropriate, to treat patients of any age with both single and multiple level disc degeneration. In addition, some patients who experience sciatica, or pain that radiates down the leg, along with back pain, will be able to receive the implant.
Artificial disc replacement is designed to restore stability and provide more range of motion. Surgery is performed by making an incision in the abdomen below the belly button. Organs are moved to the side, and the affected disc is removed. Two endplates of the artificial disc are pressed into the vertebrae above and below the disc space so that teeth along the border of the endplate grip into the bone. The artificial disc is then implanted. The disc stays in place because of the comprehensive force of the spine. The hospital stay for this procedure is approximately three days. Patients can begin rehabilitation and return to daily activities soon after artificial disc surgery.
The Charité artificial disc will be the first and only such device to receive approval.
The Chicago Institute of Neurosurgery and Neuroresearch is one of the nation's leading organizations for the diagnosis, treatment and rehabilitation of people with brain and spine disorders. Originally founded in 1987, CINN is the Midwest's largest team of neurosurgeons known for their pioneering treatments in minimally invasive techniques. Through a network of eight hospitals spanning two states, CINN treats more patients with brain tumors and spine disorders than any other physician group in Illinois.
The Neurologic & Orthopedic Hospital of Chicago is the country's first freestanding acute care hospital dedicated exclusively to neuroscience and orthopedic services. It utilizes breakthrough technology and minimally invasive techniques as well as advanced procedures for neurosurgery, orthopedics, pain management, neuro-oncology, sports medicine, and rehabilitation.
