FDA Approves IDE to Evaluate AMPLATZER Cardiac Plug

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AGA MedicalThe U.S. Food and Drug Administration (FDA) Approved Investigational Device Exemption (IDE), developed by AGA Medical Holdings. Mainly, IDE is developed for evaluating the safety and efficacy of its AMPLATZER® Cardiac Plug, or ACP, to close the left atrial appendage.

President and Chief Executive Officer of AGA Medical, John Barr said, “Approval of this study will now allow us to further evaluate our approach to reducing strokes in patients with atrial fibrillation by using our AMPLATZER Cardiac Plug to permanently seal the appendage, hopefully sparing patients from spending the rest of their lives on anticoagulants.”

However, the study's trial design will include a feasibility phase to be followed by a pivotal phase. Then, the results of the feasibility phase will serve to validate safety conclusions demonstrated through pre-clinical testing.