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"We believe the new ADO II represents a development milestone for AGAMedical and demonstrates the success of our product development programs,"said Franck Gougeon, President and CEO of AGA. "It is our first approvedocclusion device designed to treat structural heart defects that does notinclude fabric to assist in rapid occlusion. This expands the type of ductsthat can be closed by our family of PDA devices."
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The ADO II is a self-expanding nitinol mesh device and is designed to beintroduced in a minimally invasive fashion through a catheter. The device hastwo retention disks positioned on either side of the duct and connected by awaist. The ADO II is designed with a screw mechanism for attachment to thedeployment cable that allows the device to be withdrawn and repositioned, ifnecessary, prior to release from the cable.
The device treats a PDA. The ductus arteriosus is an open channel in everyfetus that allows blood to bypass the lungs, which are not used until the babytakes its first breath after birth. Shortly after the baby's first breath,the ductus arteriosus should close permanently. If it does not close, it isknown as a PDA. This condition can cause symptoms such as fatigue, difficultyor rapid breathing, failure to grow normally, or chronic respiratoryinfections such as colds and pneumonia, or endocarditis.
"The ADO II greatly improves treatment options for babies and youngchildren because it can be used with very small diameter catheters," said Mr.Gougeon.
The original Amplatzer Duct Occluder received the CE Mark in 1998 and wasapproved by the U.S. Food and Drug Administration ("FDA") in 2003. It iscurrently under review by Japanese regulatory authorities. AGA shipped morethan 51,000 Amplatzer Duct Occluders in the United States, Europe and otherinternational markets as of December 31, 2007. AGA has applied with the FDAto conduct a clinical trial in the U.S. to support approval for the ADO II.
ABOUT AGA MEDICAL: AGA Medical Corporation, based in Plymouth, Minnesota(just outside Minneapolis), is a leader in developing interventional devicesto treat structural heart defects. As a result of the many contributions andcreative genius of Dr. Kurt Amplatz, AGA develops and commercializes a seriesof devices that have revolutionized the treatment of the most commoncongenital "holes in the heart" such as atrial septal and patent foramen ovaledefects. The company is expanding into new areas such as the minimallyinvasive repair of vascular abnormalities. More than 770 articles have beenpublished in medical publications that support the benefits of AGA devices,including improved patient outcomes, reduced length of stay and acceleratedrecovery times for the patient. AGA Medical devices have received regulatoryapproval and are marketed in 101 countries with more than 278,000 devicesshipped to date. For more information visit www.amplatzer.com.MEDIA CONTACT: Jake Sargent Brunswick Group LLC 202.393.7337 [email protected]
SOURCE AGA Medical Corporation
