F.D.A. Approves a Hip Resurfacing ImplantBy BARNABY J. FEDER
Published: July 4, 2007
The regulator approved Corin’s Corment implant, bringing competition to the increasingly common procedure.
Hip resurfacing, a popular alternative implant to total hip replacement for younger patients disabled by hip failure, is about to become competitive.
The Corin Group of Britain and Stryker said yesterday that the Food and Drug Administration had approved the Cormet hip resurfacing implant by Corin, thus giving American consumers an alternative to Smith & Nephew’s Birmingham hip resurfacing system for the first time since the F.D.A. approved that device in May 2006.
Stryker, based in Kalamazoo, Mich., has a 10-year distribution agreement with Corin covering sales of the device in the United States. Stryker said that it hoped to have enough orthopedic surgeons complete the training program agreed upon with regulators to begin marketing the Cormet by the end of September.
Although total hip replacement has become a common and exceedingly successful operation for patients whose natural hip has been irreparably damaged by illness or injury, resurfacing has attracted surgeons and many patients because it preserves more of a patient’s thigh bone. That makes it easier to replace the original implant with a total hip in the future if necessary, which is often the case for active patients who have their artificial hips for 15 or 20 years.
Some hip resurfacing advocates say the procedure also leads to quicker recoveries, greater range of motion in the hip and a more natural distribution of weight and pressure on the thigh bone, or femur.
Skeptics say that much is still unknown about the long-term safety and durability of the resurfacing devices compared with the total hips and that most patients, particularly those older than 65, should stick with the older technology.
Analysts have forecast that 10 percent to 15 percent of the nearly 300,000 Americans a year who get hip replacements might be good candidates for resurfacing. Both operations cost $25,000 or more at most hospitals that offer them.
The F.D.A. action came more or less when Wall Street had forecast, based on the support for the device by the F.D.A. panel that reviewed clinical trial results in February. About 8 percent of the 302 resurfacing patients in the trial needed revision surgery within two years, a figure that the panel and the companies agreed highlighted the importance of carefully training doctors to identify which patients were most likely to have good outcomes.
The approval was announced after trading ended on Wall Street yesterday. Shares of Stryker, which are up more than 16 percent this year, rose 49 cents, to $63.95. Shares of Corin rose 1.64 percent, to 559 pence, on the London Stock Exchange.