FDA Approves New Spinal Disc Implant To Replace Degenerated Discs in Lower Back
FDA on Tuesday approved Charite, a new spinal disc implant manufactured by Johnson & Johnson, to replace degenerated discs in the lower back, the Wall Street Journal reports (Hensley, Wall Street Journal, 10/27). J&J division DePuy Spine will market Charite discs, which consist of high-density plastic between two metal plates, for use in certain parts of the lower back among patients who experience chronic pain in those areas and have "relatively strong bones," the New York Times reports (Feder, New York Times, 10/27).
J&J developed Charite discs for patients who continue to experience lower back pain after at least six months of nonsurgical treatment (Ritter, Chicago Sun-Times, 10/27). Charite discs will cost an estimated $11,500 each, which does not include the cost of surgery.
Surgeons currently treat chronic lower back pain with spinal fusion, a procedure performed more than 200,000 times annually. However, spinal fusion does not eliminate pain in all cases and can limit flexibility. Scott Blumenthal, lead investigator in a large clinic trial of Charite discs and an orthopedic spine surgeon at the Texas Back Institute, said that many spinal fusion patients "would be suited for disc replacement."
In the trial, researchers compared the outcomes of 205 patients who received Charite discs with 99 who underwent spinal fusion and found that participants in both groups experienced similar rates of complications, which included inadequate pain treatment, wound infection and mild numbness. Participants who received Charite discs also said that they maintained spinal flexibility and experienced reductions in pain (Wall Street Journal, 10/27). In addition, participants who received Charite discs took less time to recover and were more satisfied than those who underwent spinal fusion (Chicago Sun-Times, 10/27).
Some surgeons said that they have concerns about the durability of Charite discs over time. J&J said that Charite discs passed standard mechanical tests that compressed and released them 10 million times, the standard for artificial knees and hips. According to J&J, a French physician who conducted a 10-year trial that examined the longevity of the Charite discs will release the results this week at a meeting of spine surgeons in Chicago (Wall Street Journal, 10/27).
According to the New York Times, "spinal disc implants are projected to become a billion-dollar market for medical device companies" within the next 10 years. Analysts predict that J&J will not face competition in the U.S. market for lower back spinal disc implants over the next two years, although Medtronic, Sythes-Stratec and other medical companies likely will challenge J&J in the long term.
Goldman Sachs analyst Lawrence Keusch estimates that Charite discs will account for no more than 20% of the lumbar spinal fusion market and said that the current lack of surgeons trained to implant them could limit sales in the short term (New York Times, 10/27). J&J officials said that the company next month will begin to train surgeons to implant the discs (Wall Street Journal, 10/27).