FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates (Gore) today announced that the U.S. Food & Drug Administration (FDA) granted approval for the GORE HELEX Septal Occluder with modified catheter delivery system indicated for the transcatheter closure of atrial septal defect (ASD). An ASD is a congenital heart defect that affects thousands of patients every year. The GORE HELEX Septal Occluder is a permanently implanted prosthesis and the first device of its kind to use ePTFE, a biocompatible material that allows tissue ingrowth, to seal the defect. The recently approved catheter-based delivery system allows for easier device deployment via standard femoral venous access, bringing the GORE HELEX Septal Occluder to the forefront of non-surgical ASD repair.
