FDA Approves World’s Smallest Mechanical Heart Valve for Newborns & Infants!
By Adam Pick on March 8, 2018
Big News! Great News! Awesome News!
Yesterday, I learned that the FDA has approved the world’s smallest mechanical heart valve replacement from Abbott for pediatric patients. This valve, known as the Masters HP 15mm mechanical heart valve, will enable doctors to treat newborns and infants needing mitral valve or aortic valve replacement.
There are so many reasons why this is important for our community:
- First… Congenital heart defects affect 40,000 births each year. As we have seen, many pediatric patients and their families struggle with valvular defects.
- Second… Nearly one-in-four children with critical heart defects may require surgery or other procedures in their first year of life.
- Third… Until yesterday, surgeons could only use larger-sized valves that were often not suitable for the youngest children.
- Fourth… This new valve is the size of a dime. It is the only valve designed and suitable for use in newborns and infants.
Click here to see a touching video about Sadie Rutenberg who was the first infant to receive this new valve during the clinical trial leading to FDA approval. This wonderful valve from Abbott is the 7th mechanical valve to join the Abbott Masters series line.
Reflecting on this new valve for newborns and infants, Kirk R. Kanter, M.D., professor of surgery and director of the Heart Transplant Program at Children’s Healthcare in Atlanta at Emory University School of Medicine, stated, “In my practice, I want to be able to provide a treatment option that works for a critically ill child when a larger-sized valve may not be suitable. The approval of this smaller pediatric mechanical heart valve provides surgeons with a much-needed option for treating these vulnerable, high-risk children.”
Dr. Kirk Kanter
On behalf of our community, I want to extend an extraordinary “Thank You!” to all the great people at Abbott for developing this amazing valve! I am so hopeful this life-saving technology will provide a new treatment option for such a large unmet need!
Keep on tickin!