Three years ago, Lee’or Rutenberg and his wife knew their baby girl Sadie would be born with heart problems that proved to be more complex than they thought. Within months, young Sadie became the first patient to receive a pediatric heart valve as part of the HALO clinical trial,which enrolled pediatric patients five years of age or younger with a diseased, damaged, or malfunctioning heart valve across the U.S.
The FDA recently approved Abbott's Masters HP 15mm rotatable mechanical heart valve, the world’s smallest and only mechanical heart valve designed for newborns and infants in need of a mitralor aortic valve replacement. This new valve now offershope for those pediatric patientsin urgent need of a valve replacement who may have no other approved options.
