LIFE-SAVING HEART HELP GETS CE MARK

Already approved in U.S., two life-saving devices now cleared for babies and children in Europe.

heart health

Sep 17 2019

Every year, 36,0001 children are born with congenital heart defects in Europe.

Now, better than ever before, we can help each one of them.

With new approval for use in Europe, our Masters HP 15mm heart valve and Amplatzer Piccolo Occluder are now available to help those children.

Already offered in the U.S., the life-changing technologies are helping infants at their most vulnerable when other suitable treatments may not exist.

That was the case for Sadie, who was born with a congenital heart problem called complete atrioventricular canal defect. In simple terms, it’s a hole between the upper and lower chambers of the heart, where the middle is essentially missing.

When two surgeries didn’t completely fix the problem, Sadie received the first 15mm Masters valve as part of a trial. Now, she’s thriving at home, growing up healthy.

“When our doctor told us the Abbott valve worked, and that it improved her heart function as much as it did ... as a parent, I can’t put into words the happiness and emotion I felt. It’s a moment I’ll never forget,” said Sadie’s dad, Lee’or.

It was a similar experience for Irie, who received an Amplatzer Piccolo Occluder.

She and her twin brother Judah were born prematurely at 27 weeks. Their parents knew the first days of their lives wouldn’t be easy.

Irie was struggling against a life-threatening congenital defect called a patent ductus arteriosus, or PDA, which is an opening between two blood vessels leading from the heart that is also present in normally developing fetuses.

For most babies, that opening seals itself shortly after birth.

“We saw that Irie’s heart was enlarging in size and more and more fluid was collecting in her lungs,” said Aimee Armstrong, MD, director of Cardiac Catheterization and Interventional Therapies at Nationwide Children’s Hospital, and Irie’s cardiologist.

Dr. Armstrong suggested Irie may benefit from a Piccolo occluder. Dr. Armstrong was right.

Within days of receiving her occluder, Irie was able to breathe on her own and was taken off the ventilator. She’s now at her home, growing and thriving. Just like Sadie.

"You have to live it to fully appreciate what that device did for our daughter,” said Matt, Irie’s dad. “Three days after the procedure, she was making great progress.”

And now these devices can help children in Europe born with congenital heart issues as they begin their first days of life. We have prioritized making more devices, diagnostics and nutritional products available for more patients to help stop challenging conditions in their tracks for our youngest patients.

“Devices like these are among the best examples of our promise to help people live their fullest lives — in this case, young babies and children for whom these are treatments are nothing short of miraculous,” said Michael Dale, vice president of Abbott’s structural heart operation.

For more on our structural heart portfolio — including MitraClip’s extended indication and its next generation — please click here.

 

For U.S. Important Safety Information about the Amplatzer Piccolo Occluder, please click here.

For U.S. Important Safety Information on the Masters HP Series, visit click here.

1 Dolk, Helen et al. Congenital heart defects in Europe: prevalence and perinatal mortality, 2000 to 2005.”Circulation123 8 (2011): 841-9.

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