AGA Medical Gets FDA Go Ahead on Vascular Plug


August 24, 2007

August 24, 2007 - AGA Medical Corp. announced today that it has received FDA and European CE Mark approvals for the AMPLATZER Vascular Plug II ("vascular plug II"), is a self- expandable nitinol mesh occlusion device designed to be introduced in a minimally invasive fashion through a catheter.

The delivery cable that comes pre-attached to the AMPLATZER Vascular Plug II uses the unique AMPLATZER user interface to enable the physician to more precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released. The vascular plug II is designed with multiple lobes to facilitate rapid clotting.

The vascular plug comes in sizes ranging from 3 millimeters to 22 millimeters, enabling treatment of a wider range of vessel sizes. Unlike competing devices, a single vascular plug II is generally required to occlude the targeted vessel reportedly making it a cost and time effective alternative.

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