Thursday, June 16, 2011

J&J wins U.S. approval for hip replacement system

(Reuters) - A ceramic-on-metal artificial hip system made by Johnson & Johnson for patients with osteoarthritis has won U.S. approval, the Food and Drug Administration said on Tuesday.
The approval provided some welcome news for J&J's DePuy orthopedics division. The company is facing a rash of personal injury lawsuits from patients who received older hip replacement products that were recalled last year due to defects.

J&J's new Pinnacle CoMplete Acetabular Hip System is the first to combine a ceramic ball and a metal socket, the FDA said. Previously approved hip replacement systems have used different combinations of metal, ceramic, and polyethylene.

"Orthopedic surgeons and their patients now have an additional option for total hip replacement," said Christy Foreman, director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health.

The approval is based on a two-year clinical trial, which found no clinical difference between 194 patients who received the new ceramic-on-metal system and 196 patients in a control group who received a metal-on-metal hip implant.

The DePuy unit on August 26 said it was recalling its ASR XL Acetabular System and ASR Hip Resurfacing System -- both used in hip replacement surgery -- due to the number of patients requiring a second hip replacement procedure, or a revision. Some 93,000 people around the world have the ASR hip implant, a metal-on-metal resurfacing device.

J&J cited a five-year revision rate of about 12 percent for the ASR Hip Resurfacing System and about 13 percent for the ASR XL Acetabular System, a rate that industry analysts said was high.

The recall came just days after the FDA warned DePuy to stop marketing its Corail Hip System for unapproved use.

The ASR Hip Resurfacing System was introduced in 2003. The ASR XL Acetabular System was launched in 2004 and has been available worldwide.

(Reporting by Ransdell Pierson and Lewis Krauskopf, editing by Dave Zimmerman)

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