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Medical devices needed for children.

Publication: FDA Consumer
Publication Date: 01-SEP-05
Format: Online
Delivery: Immediate Online Access

Article Excerpt
Designing a rib-replacement device for children was the easiest part of a 15-year medical crusade by Texas orthopedic surgeon Robert C. Campbell. Finding a company willing to make the device was the difficult part.

The device had to be implantable, expandable, and effective in helping children overcome lung-constricting spine deformities as they grew to reach skeletal maturity. And at the time, only one child stood to benefit from the titanium rib, suggesting limited, if any, financial incentive for the manufacturer.

Today, more than 300 children are breathing, moving, and walking with newfound hope after approval of the Vertical Expandable Prosthetic Titanium Rib (VEPTR) by the Food and Drug Administration in 2004.

Medical devices such as the VEPTR help reduce the burden of illness and injury and improve the quality of life for countless children. But the titanium rib is one of only a few devices made exclusively with the special needs of children in mind. That's because pediatric medical devices, those that treat or diagnose diseases and conditions from birth through age 21, are a challenge to design and develop. In fact, doctors often are forced to use medical devices approved to treat adults on children by making them smaller, or by mechanically modifying them to fit smaller bodies. And that widespread practice, doctors say, can be risky.

"There's a...

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