Combined prospective United States clinical study data for the GORE® HELEX® septal occluder device

Abstract

Our goal was to summarize the outcome for all subjects evaluated during a prospective clinical study in the United States with the GORE(®) HELEX(®) Septal Occluder for transcatheter repair of secundum atrial septal defects (ASD). The GORE(®) HELEX(®) Septal Occluder is currently utilized for repair of secundum ASD. No previous reports are available that summarize the combined clinical trial outcomes for this device. In the United States between 1999 and 2009, 435 subjects were enrolled through the Feasibility, Pivotal, Continued Access, and Post-Approval Studies. All subjects enrolled through these studies were collectively reviewed as the "study cohort." Clinical success, defined as a composite evaluation of safety and efficacy, is reported for subjects at the 12-month follow-up period. Of the 435 device subjects enrolled in the four clinical studies, 412 subjects were eligible for follow-up. Device efficacy, as represented by clinical closure at 12 months, was achieved in 98.3% of subjects, and in 99.5% of those receiving a device whose nominal diameter was greater or equal to twice the balloon sized defect diameter. Through 12 months following implantation, freedom from major adverse events was 95.2%. Together, these results yield a 93.0% composite clinical success at 12 months following the index procedure. The combined clinical study cohort represents the largest prospective, controlled clinical trial data set available for the GORE(®) HELEX(®) Septal Occluder. The clinical data presented in this report reaffirm the safety and efficacy of the GORE(®) HELEX(®) Septal Occluder when utilized for secundum atrial septal defect repair.