Abbott's Masters HP, the world's smallest mechanical heart valve measuring only 15 millimeters, has saved the life of a three-year-old girl from Seattle who was born with a congenital heart defect.
As early as the first 12 months of her life, Sadie Rutenberg already had two open-heart surgeries, both of which were ineffective in treating her complete atrioventricular canal defect or CAVC.
Unfortunately, an organ transplant was not an option. Back in 2015, her tiny body was rendered as too weak to survive the delicate procedure. In fact, only a machine kept her breathing.
"All expectations were ... if we didn't do something fairly quickly that she was going to die," says the patient's father Lee'or in a report.
Abbott Masters HP: Creating Medical Miracles
Sadie was only eight months old when she received the Masters HP heart valve under a surgical trial conducted in Seattle Children's Heart Center.
It all began when the hospital's co-director and chief of pediatric cardiovascular surgery Dr. Jonathan Chen approached the young patient's family. He asked them if they wanted to try a revolutionary heart procedure to give Sadie a chance at life.
At that time, Abbott's dime-sized device lacked the approval of the U.S. Food and Drug Administration. However, the Rutenberg family agreed to have it installed inside their child.
According to Sadie's mother Wendy, they didn't have any other option and that they felt excited about the trial.
By May 2015, the Masters HP heart valve was successfully connected to Sadie's heart, and she became the first patient in the trial to have it fitted inside her body.
What Is Complete Atrioventricular Canal Defect?
People born with CAVC have a huge hole right in the middle of their heart. This affects all four chambers of the organ, explains the American Heart Association.
In normal conditions, blood containing oxygen from the lungs do not mix in with blood from the body, which lacks oxygen. As a result, both kinds of blood are combined in a heart with CAVC, making the valves ineffective in coursing blood to their appropriate station for circulation.
When blood lacking oxygen is pumped into arteries meant for the lungs, it makes the heart and lungs work much harder. Such may also lead to lung congestion.
Sadie Rutenberg: Proof Of Second Chances
Now aged three, Sadie is still dependent on blood thinner and will need a valve replacement when she is older. Nonetheless, she is growing up to be an active young girl.
"Abbott's new mechanical pediatric heart valve is a life-changing technology for the smallest pediatric patients, giving them a better chance at a long, healthy life with a fully functioning heart," says the manufacturer's vice president for structural heart business Michael Dale in an official statement.
The approval of the world's smallest mechanical heart valve by the U.S. Food and Drug Administration was announced on March 6.