Gore's updated septal occluder:
This article was originally published in Clinica
Executive Summary
WL Gore and Associates' next-generation version of its Gore Helex septal occluder has been granted premarket approval (PMA) by the US FDA. The implantable device, used to close up atrial septal defects (ASDs), has a modified catheter delivery system, which enables easier device deployment via standard femoral venous access, claimed the Flagstaff, Arizona firm. The Gore Helex is made of the biocompatible material ePTFE, which encourages tissue ingrowth, and is supported by a nitinol wire frame. Cells grow across the device to eventually occlude the ASD, to prevent shunting of blood between the two atria. The original Gore Helex device was approved in August 2006. The device is most often used to treat children with ASD.