FDA Allows Exemption for Pacemaker

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.

Alexandra Schuck, born six weeks early with a congenital heart condition, was fitted with the pacemaker, about the size of a quarter, just after birth last month.

The new heart-regulating device, called a “Microny” and developed by St. Jude Medical in St. Paul, Minn., 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 trials and this baby could have had dire complications without it, so we appealed to the FDA to let us use it,” Dr. Seshadri Balaji, a pediatric cardiologist, said Tuesday.

Alexandra’s mother, Erin Schuck, said her doctor found the problem about four months into her pregnancy.

“Because of Alexandra’s heart problems, she will always need a pacemaker, but that should not have any adverse affect on her life,” said Balaji.

The small pacemaker performs all the functions of a larger device and may not need replacement as Alexandra matures, doctors said.

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