FDA Approves World’s Smallest Mechanical Heart Valve

The FDA recently approved the 15mm rotatable mechanical heart valve, the world’s smallest and only mechanical heart valve designed for newborns and infants in need of a mitral or aortic valve replacement. This new valve now offers hope for those pediatric patients in urgent need of a valve replacement who may have no other approved options.

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.

Sadie’s father Lee’or, along with the doctor who performed Sadie’s surgery, Dr. Jonathan Chen, co-director of the Seattle Children's Hospital Heart Center and division chief for pediatric cardiothoracic surgery, meetup with EverydayFamily's Shiloh Johnson to talk about the FDA approval of this new mechanical heart valve and how Sadie is doing today.