On August 14, 2006, the PRODISC-L Total Disc Replacement was approved by the US Food and Drug Administration for use as a treatment for functionally disabling pain from lumbar degenerative disc disease.
The PRODISC is made by Synthes Spine. It is in the same class of devices as Johnson & Johnson's Charite lumbar artificial disc, which was approved for use in the US in October 2004 and to date has been the only artificial disc available to the general public in the US.
Initially, only the surgeons who have been part of the Prodisc clinical trials are trained to implant the Prodisc, but Synthes plans to quickly start a comprehensive training program for other surgeons to learn how to do the procedure. Training will involve two separate structured courses, and will include didactic instruction, case reviews, skills labs, cadaver spine insertion, and live surgical demonstration. Individual proctoring will also be available to surgeons.
Indications for the PRODISC-L
In its approval letter to Synthes, the FDA confirmed that the indications for use of the PRODISC-L are as follows:
- Pain from degenerative disc disease (pain caused by a degenerated disc that is confirmed by the patient's history and radiographic tests, such as MRI)
- The patient must be skeletally mature
- The artificial disc is limited to use at one level of the spine, between L3 and S1
- The patient may have no more than a grade 1 level spondylolisthesis
- The patient must have failed to find pain relief after trying at least 6 months of non-surgical therapies, such as physical therapy, medications and injections.
Goal of the PRODISC-L
The PRODISC®-L Total Disc Replacement is an implant designed to mimic the form and function of a healthy intervertebral lumbar disc. It is implanted during a surgical procedure (called spinal arthroplasty) after the diseased or damaged intervertebral disc has been removed. The goal of artificial disc replacement is to alleviate the pain caused by the damaged disc while preserving some or all of the natural motion of the lumbar spine. By preserving the natural motion, it is hoped that the adjacent levels of the spine will not be subject to additional stress as they are in traditional fusion surgery.
More Disc Replacement Info
As a condition of approval, Synthes Spine is required to conduct a five year study assessing the long-term safety and effectiveness of the disc. The study will include the 286 patients who participated in the pre-approval clinical trials. The company is also required to complete an annual analysis and report any major adverse events (such as implant breakage, subsidence or expulsion from the disc space). These conditions are similar to those imposed on the Charite artificial disc.