GORE HELEX Septal Occluder
The GORE HELEX Septal Occluder is a permanently implanted prosthesis and catheter delivery system indicated for the transcatheter closure of ostium secundum atrial septal defects (ASDs).
FDA Approves GORE HELEX Septal Occluder for Treatment of Atrial Septal Defect 03 October 2007 - W. L. Gore & Associates today announced that the US 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).