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news.Aga Medical, a developer of interventional devices, has received European CE Mark approval for its Amplatzer cardiac plug.
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According to the company, the Amplatzer cardiac plug (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.
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 with the FDA for clearance to begin a clinical trial in the US in the first half of 2009.
John Barr, president and CEO of Aga Medical, said: “Receiving CE Mark approval for the ACP is a significant milestone for Aga Medical. This device exemplifies our commitment to making structural heart devices that are clinically relevant, safe and easy to use.”