Synthes Prodisc PMA Approved by FDA
French orthopaedic spine surgeon Thierry Marnay first started designing the ProDisc artificial disc replacement in the late 80’s. He started implanting it in 64 patients for trials between 1990 and 1993. Long term results were studied in 1999 showing no adverse effects or complications. Since its approval in Europe the ProDisc has been implanted in more than 8,000 patients there. Now the PRODISC-L Total Disc Replacement has been approved by the FDA for U.S. sales. In its approval letter (pdf) the administration outlines postapproval requirements including a long-term safety and effectiveness study that the company will have to conduct and report, as well as yearly analyses of adverse events.
The device is an artificial intervertebral disc made from metal and plastic that is used to treat pain associated with degenerative disc disease (DDD). The FDA defines DDD as a discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies (DDD is actually not a disease and the condition is still debated by the medical community). The Prodisc is implanted to replace a diseased or damaged intervertebral disc during a procedure called spine arthroplasty. Synthes-Stratec acquired the product with its owner Spine Solutions in 2003. DDD was up to now treated with a variety of non-surgical treatments including anti-inflammatory medication, physical therapy, epidural steroid injections, and exercise programs. Surgery is used for the most painful cases when other options have failed. Currently spine surgeons use disc fusion to stop the motion of the spine at the level of the degenerated disc and relieve the pain.
August 16, 2006 Related topics: Product Approval & Certification, Surgery, Orthopedic