Self-Expanding Nitinol Mesh Occlusion Device Receives FDA Nod


November 12, 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"), 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 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 and 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 reportedly making it a cost- and time-effective alternative.