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News Release - August 16, 2006
FDA Approves ProDisc-L for Treatment of Low Back PainTexas Back Institute Served as One of the Lead Investigators on New Motion Preserving Device Which Offers Alternative to Spinal Fusion Surgery
PLANO, Texas--(HSMN NewsFeed)--Aug. 16, 2006--Texas Back Institute's Center for Spine Arthroplasty announced today that the U.S. Food and Drug Administration (FDA) has approved the Synthes' ProDisc-L device, an artificial disc used to replace damaged or worn out discs in order to treat severe low back pain. Since Texas Back Institute (TBI) surgeon, Jack E. Zigler, M.D., performed the first ProDisc-L implant in the U.S. in October 2001, TBI has led the way in research during the ongoing process of the device's approval. More ProDisc-L devices were implanted at TBI than at any other center in the U.S. during the pivotal trial on single-level lumbar disc disease.
Developed by a French spine surgeon, the Synthes' ProDisc-L total disc replacement has more than 15 years of clinical follow-up in Europe. Texas Back Institute served as the highest enrolling site among the 19 centers in the U.S. that conducted FDA-approval trials of the device, comparing its clinical effectiveness and safety to 360 degree fusion at any of the lowest three lumbar disc levels.
"We are thrilled to have been one of the lead investigators in the ProDisc-L study," said Zigler, principal investigator of the ProDisc-L at Texas Back Institute. "The ProDisc-L is an extraordinary device and we are excited about this FDA approval, which will make it available to our patients in the U.S. This will give our patients another surgical alternative to fusion."
Between each of the vertebrae in the spine is a spongy disc. The discs, collagen rings surrounding a gel/fluid-filled nucleus, act as shock absorbers, ensuring vertebrae are properly separated and cushioned, and that the spine remains flexible.
"Damage to discs can be caused by injury or just by aging," said Zigler. "Worn discs may cause pain between vertebrae once they lose their cushioning effect, or may place pressure on nerves, causing muscle spasm and intense leg and back pain."
The ProDisc-L is only the second artificial disc replacement device approved in the U.S.
"The ProDisc-L is comprised of two metal plates that press into the surrounding vertebrae, and hold a polyethylene dome in place," said Ralph F. Rashbaum, M.D., co-founder of Texas Back Institute and a ProDisc-L investigator. "After being implanted, the ProDisc-L device is designed to perform and move like the body's own spinal disc, helping to maintain the position of the disc space while allowing for the flexibility to bend and twist."
Lower back pain due to the degeneration of discs affects almost every American at some point in their lifetime. Each year, approximately 200,000 Americans undergo lumber spinal fusion, the most common surgical treatment for low back pain from degenerative disc disease. In spinal fusion surgery, the damaged spinal disc is removed and vertebrae are joined together using bone grafts. Often metal screws and rods are used as well to improve fusion rates so that motion can no longer occur in that area of the spine.
Although fusions relieve back pain, they may significantly limit range of motion and place extra stress on discs above and below the fusion site. Fusions usually require patients to wear a back brace for several months and require an extended period of rehabilitation, whereas ProDisc-L implant patients require only a short period of soft bracing and a quicker return to normal function. About 20 percent of fusion patients require additional surgery for an adjacent disc problem within ten to fifteen years.
"Our patients are showing significant improvements in recovery with ProDisc," said Barton Sachs, M.D., MBA with Texas Back Institute. "Almost all of our ProDisc-L patients are up and walking the afternoon of surgery, usually with little pain." Patients are typically hospitalized for one to two days after surgery.
Clinical trials comparing artificial disc replacement to spinal fusion surgery show that ProDisc-L recipients maintained or improved their range of motion, experienced pain relief sooner, had a quicker recovery and were more satisfied with the procedure than the fusion patients. They spent less time in surgery and left the hospital, on average, one day sooner than patients who had fusions. At two-year follow-up, the ProDisc-L patients were more satisfied with their outcomes than the fusion control patients. No significant differences in complications were found.
Two surgeons work together in a standard artificial disc implantation procedure. A general surgeon approaches the spine through an incision in the abdomen and carefully moves blood vessels and internal organs out of the way to provide access to the spine. A spine surgeon then removes the damaged disc to create a space between two vertebrae for the implantation of the artificial disc, which is done using fluoroscopic guidance. Generally, the procedure takes about 60 to 90 minutes for a single level.
"I feel great after my surgery," said Paul Deasy, a host with the television shopping network HSN and a ProDisc-L patient. "I am very pleased with the outcome. I have my life back and can move forward with all of the things I enjoy."
Before the FDA approval of the ProDisc-L, the CHARITE implant was the only artificial disc approved for the lumbar spine, which was available to patients in the U.S. through the Texas Back Institute's Center for Spine Arthroplasty. The center also participated in the two-level ProDisc-L FDA study (which is not yet completed), and is currently conducting FDA investigational trials for Synthes' ProDisc-C, which is designed as an artificial cervical disc to treat neck pain. In addition, there are four additional artificial disc devices under FDA investigation at the TBI Center for Spine Arthroplasty at this time.
Artificial disc replacement is not for everyone. As with any surgery, there are possible complications that can occur. Spine surgery for low back pain should not be considered unless at least 6 months of nonoperative treatment have been tried without success. If you feel that you might be a candidate for artificial disc replacement, call Texas Back Institute at 1-888-783-1937 to make an appointment with one of our doctors.
"If it is even possible, I am even more thrilled now with my results than I was following my surgery. I have been playing basketball competitively with players at least 15 years younger than I since 8 weeks after the surgery -- and doing very well," said Deasy. "I have also been lifting weights with my 16-year-old son and will soon be in the best shape of my life since my Junior year in college thanks to the Texas Back Institute. The only reason I haven't attempted golf yet is that Dr. Zigler recommended waiting 6 months before trying that particular activity. I could not be happier. This is truly a miracle of modern science."
Source: Texas Back Institute
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