Pediatrics

FDA Allows Exemption for World's Smallest Pacemaker

Published in Medical Letter on the CDC and FDA, December 10th, 2000

A premature baby with a heart defect was fitted with what doctors say is the world's smallest pacemaker after the U.S. Food and Drug Administration granted doctors an exemption to use the experimental device.

The baby girl, born six weeks early with a congenital heart condition, was fitted with the pacemaker, about the size of a quarter, just after her birth in October this year.

The new heart-regulating device, called a "Microny" and developed by St. Jude Medical in Little Canada, Minnesota, is about a third the size of a traditional pacemaker and is undergoing FDA clinical trials.

"The device has been proven to work so far in...

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Source: Medical Letter on the CDC and FDA (2000-12-10)

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