Active Implants Manufacture...

Link  http://www.memphisdailynews.com/Editorial/StoryLead.aspx?id=100097

Though the Birmingham hip is considered the industry standard, founders of another Memphis company, Active Implants Corp., said they believe they can play leapfrog with hip resurfacing using an advanced polymer first developed for Israeli Navy boat hulls.

"We're now approved in all of Europe," said Stephen Bradshaw, president and CEO of Active Implants. "We start hip surgery this week in Germany, Italy, Greece and Israel. My technology will not be available in the U.S. for quite a while, and we already have patients planning to go to Europe to get it done."

He's careful not to criticize the FDA's gate keeping, but said that new medical technology will continue to emerge first in Europe.

"I'm going to where the market opportunity is," he said. "They do almost 200,000 hip replacements a year in Germany, so it's high volume and a more friendly regulatory environment. That's why you have medical tourism; it's not the cost, but countries outside the U.S. are getting new technology faster."

Know thy information

Younger, better informed patients are not afraid of flying to Europe or even India for surgery, Bradshaw said.
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That compels manufacturers to present accurate information on their Web sites, Waugh said, and usually to assist people in finding a doctor who is familiar with the procedure.

"Surgeons have turned this into a marketing opportunity," he said. "A person wants to go to a surgeon with experience."

The AOA hip report bodes well for all manufacturers in the arena, Bradshaw said, alleviating early concerns that resurfacing may not be viable because the components are so small compared to traditional implants. With that concern gone, he said, it's now time for companies to duke it out based on clinical performance.

The AOA exhaustively collects implant data from surgeons across Australia, publishing unbiased statistics on such things as the number of procedures, component years, and revision rates, which are repeat surgeries to replace or repair an implant.

In Australia the Birmingham hip has been implanted 6,773 times, logging 19,585 component years, a cumulative measure of years in use - a common measure when assessing durability. Of those, 166 hips saw revision, a rate of 2.5 percent, by far the lowest rate. Other brands had revision rates of 4.4 percent to 8.4 percent.

"The AOA gets excellent participation; it's one of the most compliant registries in the world," Waugh said. "Whether you're an orthopedic manufacturer or a surgeon, this is a great way to see how something performs in the real world."

Counting sheep

Expect to see Smith & Nephew use the findings in educational materials for both surgeons and consumers. The Internet has permanently altered the way people manage their health care, Waugh said, with patients armed with information to discuss with their doctors.

That's already evidenced by aging athletes who have become celebrity spokespeople for implants. Tennis star Jimmy Connor plugs the Conserve total hip, manufactured by Wright Medical Technology Inc. of Arlington. At 38, former Olympic gymnast Mary Lou Retton got a new hip from Biomet Inc. of Warsaw, Ind. Golfer Jack Nicklaus was so pleased with his hip from Stryker Corp. that he's now its spokesman.

One budding issue in orthopedics is metal ionization, the microscopic fragments of metal that rub off a device and enter the blood stream. Some early studies suggest that metal-on-metal has a higher ionization rate compared to metal-on-plastic, but there is no evidence that this has any detrimental effects. What is proven is that metal-on-plastic releases polyethylene, linked to a condition that causes bone to shrink and eventual implant failure.

A 1999 study at the Avon Orthopaedic Centre in Bristol, England, compared both types and found the metal-on-metal ionization not to be significant.

Bradshaw said he can avoid that entire concern with his polycarbonate products. In one test, researchers at Leeds University in England subjected the material to 5 million cycles - equal to about 10 years worth of walking - and found no wear.

As an aside, Active Implants is also developing an artificial meniscus, or fibrous cartilage within a joint, from the same material to treat torn cartilage in the knee. The meniscus is now undergoing field trials. Because sheep knees are similar to human knees, dozens of the animals are scampering around a pasture in Israel with a polycarbonate meniscus.<