Minimally Invasive Vascular Occlusion Device for PDA Cleared in Europe


February 11, 2008

February 11, 2008 – A new minimally invasive vascular occlusion device designed to close a patent ductus arteriosus (PDA) received European CE Mark approval.

AGA Medical Corp. (AGA) announced today it received approval for the AMPLATZER Duct Occluder II (ADO II), a self-expanding nitinol mesh device designed to occlude or close PDA, a type of congenital heart defect that occurs when a blood vessel called the ductus arteriosus fails to close after birth.

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 The ADO II is designed with a screw mechanism for attachment to the deployment cable that allows the device to be withdrawn and repositioned, if necessary, prior to release from the cable.

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