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!
Adam


Written by Adam Pick
- Patient & Website Founder

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and The Wall Street Journal.

Adam Pick is a heart valve patient and author of The Patient's Guide To Heart Valve Surgery. In 2006, Adam founded HeartValveSurgery.com to educate and empower patients. This award-winning website has helped over 10 million people fight heart valve disease. Adam has been featured by the American Heart Association and The Wall Street Journal.

Adam's Newest Blogs

Adam's Newest Posts

Breakthrough Discovery: INSPIRIS RESILIA Aortic Valve Approved by the FDA Learn More.

We Rise To #2 On Feedspot’s 2018 Top Heart Blogs & Websites Rankings! Learn More.

New Community Posts

Jill says, "The good news is the CT scan went well..."
Read more

steven a says, "i am coming up on my 4 year anniversary..."
Read more

Newest Community Post

Jill says, "The good news is the CT scan went well"
Read more

steven a says, "i am coming up on my 4 year anniversary"
Read more

Mary says, "This is my first post. My husband had"
Read more

Find Heart Valve Surgeons

Search 1,500 patient-recommended surgeons