AGA Medical Corporation has 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 a trial 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.