News, September 19, 2006 FDA Approvals: MEL 80 Excimer Laser System and Gore HELEX Septal Occluder The FDA has approved an excimer laser system (MEL 80) and a septal occluder (Gore HELEX).
Two different brands of closure devices are approved by the U.S. Food and Drug Administration for percutaneous ASD closure — Amplatzer® Septal Occluder and the GORE HELEX® Septal Occluder. The closure ...
USA), the HELEX Septal Occluder™ (W.L. Gore and Associates, AZ, USA), the Cardia Intrasept® (Cardia Inc., Burnsville, MN, USA) and others. There are no trials comparing the performance of each ...
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