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AGA Medical Corporation has received approval from the U. S. Food and Drug Administration (FDA) to market release its AMPLATZER® Septal Occluder for transcatheter closure of secundum atrial septal defects and fenestrations post Fontan operation. This is the Company's first device to be approved under PMA. This is also the first device to be approved in the United States for closure of these types of congenital heart defects. A U.S. launch of the occluders will begin immediately. 

For patients with certain types of circulatory defects, AGA Medical's patented AMPLATZER® devices offer a potential alternative to expensive, invasive surgical procedures. A physician can implant them simply and easily, through small catheters inserted in the patient's groin. 

The patient is able to return home on the same day or the following day, without the lengthy recovery period that would be required after surgery. Because of their unique design, AMPLATZER® devices can be inserted through small catheters, which makes them ideal for small children and infants.

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