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AGA Medical Corporation Receives European CE Mark Approval for the AMPLATZER(R) Duct Occluder II
Date:2/11/2008

MINNEAPOLIS, Feb. 11 /PRNewswire/ -- AGA Medical Corporation ("AGA") announced today it received European CE Mark approval for the AMPLATZER(R) Duct Occluder II ("ADO II"). AGA also announced the immediate availability and launch of the device in Europe. The ADO II expands the AGA family of occlusion devices designed to occlude or close a patent ductus arteriosus ("PDA"), a type of congenital heart defect that occurs when a blood vessel called the ductus arteriosus fails to close after birth, as it normally should.

"We believe the new ADO II represents a development milestone for AGA Medical and demonstrates the success of our product development programs," said Franck Gougeon, President and CEO of AGA. "It is our first approved occlusion device designed to treat structural heart defects that does not include fabric to assist in rapid occlusion. This expands the type of ducts that can be closed by our family of PDA devices."

The ADO II is a self-expanding nitinol mesh device and is designed to be introduced in a minimally invasive fashion through a catheter. The device has two retention disks positioned on either side of the duct and connected by a waist. The ADO II is designed with a screw mechanism for attachment to the deployment cable that allows the device to be withdrawn and repositioned, if necessary, prior to release from the cable.

The device treats a PDA. 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.

"The ADO II greatly improves treatment options for babies and young children because it can b
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SOURCE AGA Medical Corporation
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