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news.AGA Medical has received European CE Mark approval for the Amplatzer Duct Occluder II or ADO II. AGA also announced the immediate availability and launch of the device in Europe.
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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 ADO II expands the AGA family of occlusion devices designed to occlude or close a patent ductus arteriosus, 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.
Franck Gougeon, president and CEO of AGA, said: “It is our first approved occlusion device designed to treat structural heart defects that does not include fabric to assist in rapid occlusion.”