Helex Septal Occluder for Closure of Atrial Septal Defects.

Abstract

The HELEX Septal Occluder (W.L. Gore and Associates, Flagstaff, AZ) is a new device with many desirable characteristics. These include direct placement of the delivery catheter across the septal defect without the need for a long sheath; rounded, flexible and atraumatic shape; easy deployment while maintaining the ability to withdraw the device back into the delivery system at any time prior to release; safety cord to allow for removal of the device even after release from the formed elements of the delivery system; and highly biocompatible expanded polytetrafluoroethylene (ePTFE) covering. The design of the device has been thoroughly tested by computer modeling, in vitro testing, and in vivo evaluations in an animal model of atrial septal defect (ASD). Early human experience in Europe for ASD and patent foramen ovale (PFO) indications has been encouraging. Food and Drug Administration (FDA) trials in the United States are anticipated this year.