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AGA Medical Receives Japanese Approval for AMPLATZER(R) Duct Occluder
Date:1/7/2009

er was granted Conformite Europeenne (CE) Mark in Europe in February 1998 and U.S. Food and Drug Administration (FDA) approval in May 2003. AGA Medical's second generation AMPLATZER Duct Occluder - ADO II - has been granted CE Mark approval in Europe and can be delivered through even smaller catheters and is appropriate for both smaller ducts and ducts with different geometries. AGA Medical has a clinical trial underway to support approval for the ADO II in the United States.

About Patent Ductus Arteriosus

The ductus arteriosus is an open channel in every fetus that allows blood to bypass the lungs, which are not used until the baby takes its first breath after birth. Shortly after the baby's first breath, the ductus arteriosus should close permanently. If it does not close, it is known as a PDA. This condition can cause symptoms such as fatigue, difficulty or rapid breathing, failure to grow normally, or chronic respiratory infections such as colds and pneumonia, or endocarditis. PDA can also be asymptomatic. Large openings can lead to heart failure and death.

About AGA Medical

AGA Medical, based in Plymouth, Minnesota, is a leader in developing interventional devices for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease. Founded in 1995 by Dr. Kurt Amplatz, a former professor and researcher at the University of Minnesota Department of Radiology, AGA Medical develops and commercializes devices for a range of structural heart repair and circulatory conditions. Several of these devices have been major innovations in the treatment of the most common congenital "holes in the heart," such as atrial septal defects, patent ductus arteriosis, and patent foramen ovales.

More than 700 articles have been published in medical literature that support the benefits of AGA Medical devices, including improved patient outcomes, reduced
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SOURCE AGA Medical Corporation
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