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From the Food and Drug Administration
February 6, 2002

Congenital Heart Defect Devices

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Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002American Medical Association

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JAMA. 2002;287(5):578. doi:10.1001/jama.287.5.578-JFD20002-3-1

The FDA has approved two transcatheter cardiac occlusion devices that offer an alternative to surgery to treat congenital heart defects. One of the devices, CardioSeal Septal Occlusion System with QwikLoad (NMT Medical Inc, Boston), is indicated for use in patients with complex ventricular septal defects (VSDs) that warrant closure and who are considered at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions or overall medical condition.

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