Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder.

Objective: To assess the outcomes and potential predictors of residual leak after implantation of the GORE CARDIOFORM Septal Occluder (GSO) in secundum atrial septal defects (ASDs).

Background: The non-self-centering design of the GSO could lead to residual leak at the edge of the device. Outcomes of residual leak are poorly understood.

The challenges surrounding preclinical testing in transcatheter device development and the implications on the clinic.

Transcatheter devices have contributed significantly to the advances achieved in treating many cardiovascular conditions over the last few decades. Sophisticated and detailed preclinical testing is not only a regulatory requirement to support an investigational device exemption (IDE) application, but more crucially its success and accuracy is needed to safeguard patients during the subsequent clinical testing stages. Areas covered: This article covers the regulatory background as well as specific considerations related to pre-clinical testing of transcatheter devices.

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

Objectives: 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).

Background: 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.

Failure of the GORE HELEX atrial septal defect occluder to treat membranous VSDs in swine.

Objective: We tested the suitability of the GORE HELEX septal occluder for closure of membranous ventricular septal defect in three Yucatan minipigs that had naturally-occurring membranous ventricular septal defects.

Methods: The animals were studied in the Gore Science Center Laboratory in Flagstaff, Arizona. In all of the device implantations, seating of the right disk along the right ventricular septum was problematic with resultant entanglement of one device in the chordae tendinae during attempted removal, implantation of one device onto the tricuspid valve papillary muscle and unlocking of one device occurring after implantation.