Smith & Nephew monopoly lost; FDA approves device from Britain
By Daniel Connolly July 18, 2007
The Birmingham Hip implant by British medical device maker Smith & Nephew was the first hip resurfacing product to go on sale in the United States and has helped drive revenue at the firm’s Memphis-based orthopedic units.
But a recent federal decision means the company will now face a rival in the fast-growing hip resurfacing market.
Earlier this month, the Food and Drug Administration approved the Cormet 2000 hip resurfacing device from British firm Corin Group PLC. An FDA panel had recommended approval in February.
Stryker Corp. of Kalamazoo, Mich., plans to distribute the devices in the United States later this year.
When the hip goes on the market, it will break the American monopoly that the Birmingham Hip has enjoyed since its FDA approval in May 2006. Currently, it’s the only product available in the United States for hip resurfacing, a relatively new surgical procedure used as an alternative to traditional hip replacement.
Both techniques are used in patients who have osteoarthritis and other joint diseases that cause pain and limit mobility.
Proponents of hip resurfacing say it destroys less bone than standard hip replacement surgery and is better suited for younger patients who want to maintain an active lifestyle. However, some surgeons have expressed concerns about results, including about a higher-than average early failure rate.
Smith & Nephew representatives have said the product is safe and effective, and the Birmingham Hip has been a sales winner for the firm.
In the first quarter, for instance, sales of the Birmingham Hip helped increase revenue in the firm’s orthopedic reconstruction unit 15 percent to $262 million.
A Stryker spokesman declined to comment on competition with Smith & Nephew.
Brian Austin, vice president and general manager of Smith & Nephew’s hip division, expressed confidence.
"We are realizing tremendous growth, particularly in the U.S.," he said in a statement. "We have been aware of Stryker’s possible entry into hip resurfacing and are ready. … We have a world-class training program and have already trained close to 1,000 U.S. surgeons. We are continuing to exceed our growth goals and fully intend to keep our market leading position."
— Daniel Connolly
Smith & Nephew
World headquarters : London.
Worldwide employees : More than 8,500.
Local headquarters : 1450 Brooks Road.
Local employees : About 1,800.
Local presidents : Mark Augusti, president, trauma and clinical therapies division; Joseph DeVivo, president for orthopedic reconstruction.
Web site : Smith-Nephew.com.