FDA Approves Heart Valve for Babies After Trial That Started in Seattle

FDA Approves Heart Valve for Babies After Trial That Started in Seattle

The FDA has approved the first mechanical heart valve designed for infants and babies after a medical trial that started at Seattle Children’s Hospital. The Masters 15-mm valve, made by Abbott, is the smallest of its kind in the world. Sadie Rutenberg was the first child in the trial to receive the valve in May 2015 when she was 9 months old. Sadie was born with a complete atrioventricular canal defect and underwent two open heart surgeries in her first few months of life, spurring talks of a transplant. Then Dr. Jonathan Chen, the chief of congenital cardiac surgery at Seattle Children’s, approached the family with the opportunity to take part in the medical trial. Now 3 years old, Sadie is full of life.

About Seattle Children’s

Seattle Children’s mission is to provide hope, care and cures to help every child live the healthiest and most fulfilling life possible. Together, Seattle Children’s Hospital, Research Institute and Foundation deliver superior patient care, identify new discoveries and treatments through pediatric research, and raise funds to create better futures for patients.

Ranked as one of the top children’s hospitals in the country by U.S. News & World Report, Seattle Children’s serves as the pediatric and adolescent academic medical center for Washington, Alaska, Montana and Idaho – the largest region of any children’s hospital in the country. As one of the nation’s top five pediatric research centers, Seattle Children’s Research Institute is internationally recognized for its work in neurosciences, immunology, cancer, infectious disease, injury prevention and much more. Seattle Children’s Hospital and Research Foundation works with the Seattle Children’s Guild Association, the largest all-volunteer fundraising network for any hospital in the country, to gather community support and raise funds for uncompensated care and research. Join Seattle Children’s bold initiative – It Starts With Yes: The Campaign for Seattle Children’s – to transform children’s health for generations to come.

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