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The New Jersey-based company must conduct a 10-year follow-up safety study.
August 19, 2009
By: Michael Barbella
Managing Editor
A U.S. Food and Drug Administration outside panel voted 5-0 that Johnson & Johnson’s Pinnacle Complete implant system appears to be safe and effective, according to the agency.
The panel, which includes orthopedic experts, recommended the approval unanimously, but are requiring that the New Brunswick, N.J.-based company conduct a 10-year follow-up safety study.
“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, Ph.D., vice president, Worldwide Clinical Affairs, DePuy Orthopaedics Inc. “Each new implant provides orthopaedic surgeons and their patients more choices, which result in more individualized treatment based on specific patient anatomy, lifestyle, age, medical condition and surgeon preference.”
The Pinnacle device is available in 40 countries outside the United States, according to the company.
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