FDA News

AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II

(Aug 25, 2007)-- AGA Medical Corporation announced  that it has received U.S. Food and Drug Administration (FDA) and European CE Mark approvals for the AMPLATZER Vascular Plug II ("Vascular Plug II").

The AMPLATZER Vascular Plug II expands the AGA family of occlusion devices designed to embolize, or close blood vessel and blood vessel malformations in the peripheral vasculature. The AMPLATZER Vascular Plug II is a self-expandable nitinol mesh occlusion device and is designed to be introduced in a minimally invasive fashion through a catheter. The delivery cable that comes pre-attached 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 II comes in sizes ranging from 3 mm to 22 mm 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 making it a cost and time effective alternative.

"The new Vascular Plug is an important addition to our family of occlusion devices", said Franck Gougeon, President and CEO of AGA. "The Vascular Plug is among the fastest growing AGA products and we believe this new model can only help to further accelerate its growth. With more products under development that are specifically targeted for use by interventional specialists that treat peripheral vascular disease, the vascular plug is establishing a strong and exciting foundation for future diversification by AGA Medical."

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