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UPDATE 2-US panel backs new Johnson & Johnson hip implant

Published: 18 Aug 2009 21:11:23 PST

* Panel votes 5-0 in favor of ceramic-on-metal hip

* FDA usually approves devices that win panel backing

* J&J unit plans to monitor performance for 10 years

* J&J shares close barely changed, down 2 cents (Adds panel member, company quotes; updates shares)

GAITHERSBURG, Md., Aug 18 - Johnson & Johnson won a U.S. advisory panel's support on Tuesday for a novel hip replacement designed to provide more durability than current implants.

A Food and Drug Administration committee voted 5-0 to recommend approval of J&J's Complete Acetabular Hip System, an experimental implant with a ceramic head and metal liner. The ceramic-on-metal design is meant to reduce wear compared to metal-on-metal implants.

In a company-funded study, the newer implant performed as well as a metal-on-metal version in patients who had the device implanted for two years, FDA reviewers 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 and efficacious," said panel member Kathleen Propert, a statistician from the University of Pennsylvania.

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 such as Stryker, Zimmer Holdings and Smith & Nephew.

Artificial hips are implanted to relieve pain and disability from arthritis. About 193,000 total hip replacements are performed in the United States each year, DePuy said.

J&J's ceramic-on-metal hips have been used in more than 40 countries since 2007 but no such device is cleared in the United States.

The company's lab tests showed reduced wear with the Complete system compared with a metal-on-metal implant, company officials told the panel.

Studies in people showed similar success rates and 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.

The ceramic-on-metal hip offers "enhanced wear characteristics... without compromising on clinical safety and efficacy," Sally Hunter, a DePuy vice president, told the panel.

The new hip did not offer lower levels of metal ions in the body as would be expected with less wear, FDA reviewers said.

Metal ions are particles that can be released into the body and detected in patients' blood and urine. There have been concerns ion buildup might lead to cancer, immune system reactions or other harm over a period of years, but long-term data is limited and no health problems have been definitely attributed to ions from metal hips.

Still, doctors are advised not to give metal-on-metal hips to pregnant women and people with kidney disease because of concerns about the ions. The committee said the same recommendation should apply to J&J's ceramic-on-metal version, and supported the idea of measuring ion levels periodically in post-approval research.

Shares of Johnson & Johnson, a diversified healthcare products company, fell 2 cents to close Tuesday at $59.80 on the New York Stock Exchange.


Source: Reuters

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