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ABBOTT RECEIVES CE MARK FOR THE TINIEST MECHANICAL HEART VALVE

SEP. 17, 2019

Following approvals in the USA and Canada, Abbott received the CE mark for the 15mm paediatric heart valve on August 21st. 

Every year, 36.000 children are born with congenital heart defects in Europe. Now, better than ever before, we can help each one of them. With this heart valve, Abbott strives to treat young children and babies, to be able to give them a new chance in life. 
The 15mm paediatric heart valve is the world's smallest mechanical heart valve and allows doctors to treat babies and toddlers in need of a mitral or aortic heart valve replacement. This new treatment option offers young paediatric patients and their families hope when no other suitable treatment option may exist.

And now this device can help children in Europe born with congenital heart issues as they begin their first days of life. Abbott has prioritized making more devices, diagnostics and nutritional products available for more patients to help stop challenging conditions in their tracks for the 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.

Meet Sadie, 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 valve as part of a trial. Now, she’s thriving at home, growing up healthy.

Some of the content on this website relates individual patients’ responses to specific treatments. These accounts are genuine, typical and documented. However, they do not provide any indication, guide, warranty or guarantee as to the response other persons may have to the treatments. Responses to the treatments  can and do vary and are specific to the individual patient. The information provided is not intended for medical diagnosis or treatment or as a substitute for professional medical advice. Consult with a physician or qualified healthcare provider for appropriate medical advice.
 
Products intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. All drawings are artist’s representations only and should not be considered as an engineering drawing or photograph. Photo(s) on file at Abbott. Information contained herein is for distribution for Europe, Middle East and Africa ONLY. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. For more information, visit our website at cardiovascular.abbott.
 
Abbott Vascular International BVBA, Park Lane, Culliganlaan 2b, 1831 Diegem, Belgium, tel: +32 2 714 14 11

© 2021 Abbott. All rights reserved. 9-EH-8-9599-01 09-2019 REV C

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