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By MATTHEW PERRONE
AP Business Writer
FDA panel backs approval for J&J hip replacement175 days ago
(AP:WASHINGTON) A panel of federal health experts on Tuesday unanimously recommended approval for an experimental hip replacement system from health care products maker Johnson & Johnson.
The Food and Drug Administration's outside panel of orthopedic experts voted 5-0 that the Pinnacle Complete implant system appears safe and effective, according to an agency spokeswoman.
Panelists recommended approval, provided the New Brunswick, N.J.-based company conduct a 10-year follow-up safety study.
The FDA is not required to follow the panel's advice, though it usually does.
J&J's Depuy unit has asked the FDA to approve its device for patients who need a total replacement of the ball-and-socket hip joint due to damage or deterioration. A diseased hip joint can cause pain and disability.
About 193,000 total hip replacements are performed in the U.S. each year, according to the American Academy of Orthopedic surgeons.
Depuy's device uses a ceramic-on-metal design, unlike older implants made entirely from metal. The new approach is designed to help the device last longer.
J&J conducted two studies comparing the Pinnacle implant to a traditional metal-on-metal implant. After two years of tracking, patients with the Pinnacle reported significantly less wear and tear on their device than those with a traditional hip replacement. Negative side effects were similar between the two groups.
"We are pleased with the panel's recommendation, and if approved by the FDA, the Pinnacle Complete System would represent an important innovation for hip replacement in the United States," said Pamela Plouhar, a vice president with Depuy.
The Pinnacle device is already available in 40 countries outside the U.S., according to the company.
J&J shares dipped 2 cents to $59.80 Tuesday.
Copyright 2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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