Advisory panel backs new J&J hip implan

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Johnson & Johnson won a U.S. advisory panel's support on for a novel hip replacement designed to provide more durability than current implants. A FDA committee voted 5-0 to recommend approval of J&J's Complete Acetabular Hip System, an experimental implant with a ceramic head & metal liner. The ceramic-on-metal design is meant to reduce wear compared to metal-on-metal implants. In a co.-funded study, the newer implant performed as well as a metal-on-metal version in patients who had the device implanted for 2 years, they said. Members of the agency's advisory panel said the data from J&J's DePuy Orthopaedics unit provided "very clear results that completely convinced me this device is both safe & efficacious," said panel member Kathy Propert, statistician from the U of PA. The panelists backed a DePuy plan to study the implant's performance after approval in a group of patients for up to 10 years. The FDA usually approves devices that win support from its advisory panels of outside experts. If cleared, the J&J device will compete with artificial hips from companies like Stryker, Zimmer Holdings & Smith & Nephew. Artificial hips are implanted to relieve pain & disability from arthritis. 193,000 total hip replacements are performed in the U.S. each year, it said. J&J's ceramic-on-metal hips have been used in over 40 countries since 07 but no such device is cleared in the U.S. It's lab tests showed reduced wear with the Complete system compared to a metal-on-metal implant, company officials said. Studies in people showed similar success rates & pain relief with either type of hip through two years. Rates of complications and repeat operations to repair or replace the implant also were about the same. Ceramic-on-metal hip offers "enhanced wear characteristics without compromising on clinical safety & efficacy," Sally Hunter, DePuy VP, said. The new hip didn