FDA Allows Exemption for Pacemaker

P O R T L A N D, Ore., Nov. 9 -- A premature baby with a heart defect wasfitted with what doctors say is the world’s smallest pacemakerafter the U.S. Food and Drug Administration granted doctors anexemption to use the experimental device.

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

The new heart-regulating device, called a “Microny” anddeveloped by St. Jude Medical in St. Paul, Minn., is about a thirdthe size of a traditional pacemaker and is undergoing FDA clinicaltrials.

“The device has been proven to work so far in trials and thisbaby could have had dire complications without it, so we appealedto the FDA to let us use it,” Dr. Seshadri Balaji, a pediatriccardiologist, said Tuesday.

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

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

The small pacemaker performs all the functions of a largerdevice and may not need replacement as Alexandra matures, doctorssaid.