Healthcare Industry News:  AMPLATZER 

Devices Interventional Regulatory

 News Release - May 15, 2008

AGA Medical Corporation Receives CE Mark Approval for the AMPLATZER(R) Vascular Plug III

MINNEAPOLIS, May 15 (HSMN NewsFeed) -- AGA Medical Corporation ("AGA") announced today it received CE mark approval to market the AMPLATZER Vascular Plug III ("AVP III"). AGA also announced the immediate availability and launch of the device in the European Union. The AVP III further expands the AGA family of occlusion devices designed to embolize, or close, blood vessels and blood vessel malformations in the peripheral vasculature.

"We believe the new AVP III is another strong addition to the AGA vascular plug family," said Franck Gougeon, President and CEO of AGA. "Our goal is to provide physicians with a toolbox of embolization devices that can treat vessels of different types and length and with different flow characteristics."

The AVP III is a self-expanding nitinol mesh device and is designed to be introduced in a minimally invasive fashion through a catheter. The device comes pre-attached to a delivery cable by a small screw; the delivery cable enables the physician to precisely position the device in the targeted blood vessel. Once positioned, the cable is unscrewed and the device is released. The nitinol mesh retention discs ensure the secure positioning of the device even in high flow vessels.

"Our pre-clinical testing suggests that the AVP III will have the fastest occlusion times within our vascular plug family," said Mr. Gougeon.

The AVP III is under review by the Food and Drug Administration for clearance to market in the U.S.

ABOUT AGA MEDICAL: AGA Medical Corporation, based in Plymouth, Minnesota (just outside Minneapolis), is a leader in developing interventional devices to treat structural heart defects. As a result of the many contributions and creative genius of Dr. Kurt Amplatz, AGA develops and commercializes a series of devices that have revolutionized the treatment of the most common congenital "holes in the heart" such as atrial septal and patent foramen ovale defects. The company is expanding into new areas such as the minimally invasive repair of vascular abnormalities. More than 770 articles have been published in medical publications that support the benefits of AGA devices, including improved patient outcomes, reduced length of stay and accelerated recovery times for the patient. AGA Medical devices have received regulatory approval and are marketed in 101 countries with more than 278,000 devices shipped to date. For more information visit www.AMPLATZER.com.


Source: AGA Medical

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