The design and deployment of the HELEX septal occluder

The GORE HELEX Septal Occluder™ (W.L. Gore and Associates, Flagstaff, Ariz, USA) is the latest device to pursue U.S. Food and Drug Administration (FDA) approval for the closure of secundum atrial septal defects. The device is soft and compliant with comparatively little metal framework. It can be deployed and retrieved without damaging the device, and has a safety cord attached that allows retrieval even after it has been disconnected from the delivery mandrel. With FDA approval, operators will now have a choice of devices for the closure of atrial septal defects. Significant differences exist between the HELEX device and existing atrial septal occluders. This article explains the HELEX device design, provides recommendations for preprocedural screening and preparation, and discusses the deployment technique in detail. The device may be particularly advantageous for patients with small- to moderate-sized atrial septal defects.