Healthcare Industry News:  AMPLATZER 

Devices Interventional Cardiology Regulatory

 News Release - December 3, 2008

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

Device will enable minimally-invasive transcatheter closure of cardiac structures

MINNEAPOLIS, December 3 -- (Healthcare Sales & Marketing Network) -- AGA Medical Corporation announced today that it received European CE Mark (Conformite Europeenne) approval for its AMPLATZER Cardiac Plug (ACP). The ACP provides an innovative, minimally invasive solution for closing cardiac structures not involving the septal wall. One such intended use will be for the non-surgical occlusion of the left atrial appendage.

"The ACP is an important addition to the interventional tools we have for structural heart repair. The design and conformability of the device as well as its ease of deliverability will allow us to effectively occlude challenging anatomy 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 atrial fibrillation and formation of thrombus in the left atrial appendage, which can increase the risk of stroke to 5 percent per year. Physicians have limited options to minimize stroke risk other than anticoagulants which are often associated with adverse side effects."

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

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

AGA Medical will immediately begin marketing of the ACP in Europe and plans to support the broad adoption of left atrial appendage occlusion for atrial fibrillation. It will also introduce a physician clinical training program utilizing the latest medical simulation technology. The company has filed for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for clearance to begin a clinical trial in the United States in the first half of 2009.

About AGA Medical Corporation

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

More than 700 articles have been published in medical literature that support the benefits of AGA Medical 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. For more information, visit http://www.AMPLATZER.com.


Source: AGA Medical

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