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FDA APPROVES THE WORLD’S SMALLEST OCCLUDER

Jan. 14, 2019

The U.S. Food and Drug Administration (FDA) approved the world's first medical device that can be implanted in the tiniest babies (weighing as little as 700g) using a minimally invasive procedure to treat patent ductus arteriosus, or PDA. The occluder is even smaller than a small pea, creating hope for premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and a high risk to undergo corrective surgery.

This device is able to occlude a variety of duct sizes, or elongated ducts.

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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