1.0 Brief Product Description
Routine surgery for painful lumbar (low back) disc disease often involves spinal fusion. This is performed by preparing the bones, and placing graft bone between them, so that they can grow together into one bone. The success rates for this procedure are reasonable, but far from perfect. There are different fusion techniques, and results vary, depending on the patient’s individual pathology, the operation performed, and the skills of the surgeon. The option of an alternative that would replace the disc, and allow continued motion was greatly and widely anticipated within the United States. Some countries were allowing lumbar disc replacement, also termed arthroplasty, to be performed. The Charité disc was developed in Germany. It had been used in over 6,000 patients in Europe with satisfactory results. The disc was a three piece composite, with a metallic top and bottom, and a polyurethane central member that was intended to help simulate the normal motion of the spine when the patient would bend their back. Success rates in Europe were reported to be as high as 90% of patients with “Good” or “Excellent” outcomes. Clinical Studies would be required for approval by the U.S. Food and Drug Administration.
Depuy Spine, a division of Johnson and Johnson, bought the Link Spine Group, LLC for 325 Million USD in order to acquire rights to the Charité. They sponsored a clinical trial, and were granted approval by the U.S. FDA in October of 2004 by a unanimous vote. It was estimated that the U.S. market alone for disc replacements could reach 1 Billion dollars by 2010. The device was to be rolled out with a surgeon training campaign, at a price of 11,500.00 per disc. The cost of devices used in spine surgery for a one-disc fusion, the alternative procedure, varies widely, but is
