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New J & J Ceramic Hip Implant Wins FDA Advisory Approval

Posted by Jane Akre
Wednesday, August 19, 2009 11:16 AM EST
Category: Major Medical
Tags: Hip Replacement, Medical Devices, FDA, Johnson & Johnson

J & J has won FDA advisory preliminary approval for a ceramic on metal hip replacement medical device.

Ceramic On Metal

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An FDA advisory panel has voted 5-0 to approve a new hip replacement made by Johnson & Johnson. The FDA generally follows the lead of its advisory panels.

J & J’s DePuy unit asked for FDA approval for patients who need to have a total replacement of the ball-and-socket hip joint because of damage and deterioration, which causes pain and disability, reports AP.

Made of ceramic, the Pinnacle Complete Acetabular Hip System, is an experimental implant made with a ceramic head on a metal liner. J & J plans to track the performance of this novel approach for the next ten years.

The acetabulum is the concave surface of the pelvis where the head of the femur meets with the pelvis forming the hip joint.

The rates of complications, pain, and replacement of the implant were all considered by the panel.

Advisory panel member, Kathleen Propert, a statistician from the University of Pennsylvania said the data from J & J’s Orthopaedics unit provided "very clear results that completely convinced me this device ... is both safe and efficacious.”

Ceramic-on-metal is designed to cut down on the wear associated with metal-on-metal implants. In company-funded studies, the newer implant performed as well as the traditional approach in patients with the implant for two years, reports Reuters.

In metal-on-metal implants, the potential exists for the release of metal ions into the body. With less wear, reviewers expected to see fewer metal ions in the blood and urine, particles that might lead to cancer, though that connection is not firmly established.

Pregnant women and people with kidney disease should not receive the metal-on-metal artificial hips because of the concern about metal ions.

About 193,000 total hip replacements are performed in the U.S. every year. The Pinnacle devise is already available in 40 countries outside the U.S., according to J & J.

The J & J device, manufactured through its DePuy Orthopaedics unit, will compete with artificial hips from Stryker, Zimmer Holdings, and Smith and Nephew. #


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