• W. L. Gore & Associates (Gore; Flagstaff, Arizona) said the FDA granted approval for the Gore Helex septal occluder with modified catheter delivery system indicated for the transcatheter closure of atrial septal defect (ASD). The Helex 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 catheter-based delivery system allows for easier device deployment via standard femoral venous access. The Helex is composed of ePTFE patch material supported by a single nitinol wire frame that bridges and eventually occludes the septal defect to stop the shunting of blood between the atria. The Gore medical products division includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia repair and sutures for use in vascular, cardiac and general surgery.
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