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AGA Medical Receives European CE Mark Approval for AMPLATZER(R) Cardiac Plug

Wednesday, December 3, 2008 General News J E 4
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MINNEAPOLIS, Dec. 3 AGA Medical Corporation announcedtoday that it received European CE Mark (Conformite Europeenne) approval forits AMPLATZER(R) Cardiac Plug (ACP). The ACP provides an innovative, minimallyinvasive solution for closing cardiac structures not involving the septalwall. One such intended use will be for the non-surgical occlusion of the leftatrial appendage.

"The ACP is an important addition to the interventional tools we have forstructural heart repair. The design and conformability of the device as wellas its ease of deliverability will allow us to effectively occlude challenginganatomy such as the left atrial appendage," said Bernhard Meier, MD, FACC,FESC, professor and chairman of cardiology, University Hospital, Bern,Switzerland. "Scientific data suggests a strong link between atrialfibrillation and formation of thrombus in the left atrial appendage, which canincrease the risk of stroke to 5 percent per year. Physicians have limitedoptions to minimize stroke risk other than anticoagulants which are oftenassociated with adverse side effects."

Made of flexible braided Nitinol mesh, the ACP is designed to provideocclusion with full cross-sectional coverage. The ACP self-orients to thecardiac wall, covering the hole of the structure to be occluded. It leveragesthe proven microscrew technology platform used in all AGA Medical devices toprovide physicians with simple, controlled and precise delivery. This allowsthe ACP to be recaptured and repositioned if necessary, ensuring a customizeddelivery and fit for each patient's unique anatomic structure.

"Receiving CE Mark approval for the ACP is a significant milestone for AGAMedical," said John Barr, President and CEO, AGA Medical Corporation. "Thisdevice exemplifies our commitment to making structural heart devices that areclinically relevant, safe and easy to use. With approximately 5 percent of thepopulation over the age of 65 diagnosed with atrial fibrillation, it is one ofthe most prevalent conditions in this age group. We believe a very largenumber of patients will benefit from the availability of the ACP."

AGA Medical will immediately begin marketing of the ACP in Europe andplans to support the broad adoption of left atrial appendage occlusion foratrial fibrillation. It will also introduce a physician clinical trainingprogram utilizing the latest medical simulation technology. The company hasfiled for an Investigational Device Exemption (IDE) with the U.S. Food andDrug Administration (FDA) for clearance to begin a clinical trial in theUnited States in the first half of 2009.

About AGA Medical Corporation

AGA Medical Corporation, based in Plymouth, Minnesota, is a leader indeveloping interventional devices for the minimally invasive treatment ofcardiovascular defects and peripheral vascular disease. Founded in 1995 byDr. Kurt Amplatz, a former professor and researcher at the University ofMinnesota Department of Radiology, AGA Medical develops and commercializesdevices for a range of structural heart repair and circulatory conditions.Several of these devices have been major innovations in the treatment of themost common congenital "holes in the heart", such as atrial septal defects andpatent foramen ovales.

More than 700 articles have been published in medical literature thatsupport the benefits of AGA Medical devices, including improved patientoutcomes, reduced length of stay, and accelerated recovery times for thepatient. AGA Medical devices have received regulatory approval and aremarketed in 101 countries. For more information, visithttp://www.amplatzer.com.

SOURCE AGA Medical Corporation
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