AGA Medical nets FDA approval, CE Mark for vascular plug

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Interventional device developer AGA Medical reported that it has received U.S. Food and Drug Administration and European CE Mark approvals for its Amplatzer Vascular Plug II. The product is a self-expandable nitinol mesh occlusion device and is designed to be introduced in a minimally invasive fashion through a catheter.

The vascular plug is available in sizes ranging from 3 mm to 22 mm enabling treatment of a wider range of vessel sizes and is designed with multiple lobes to facilitate rapid clotting, according to AGA.

The U.S. and European approvals of the device expands the AGA family of occlusion devices designed to embolize blood vessel and blood vessel malformations in the peripheral vasculature, the Plymouth, Minn.-based company said.