A new-generation device used in the treatment of transcatheter closure of congenital heart defects provides easier delivery, better septal apposition, and faster endothelialization than an older version of the device. Early clinical experience showed the device to be efficient and successful in closing both atrial septal defects (ASDs) and patent foramen ovales (PFOs).

Joseph Paolillo, MD, Sanger Heart and Vascular Institute, Levine Children's Hospital, Charlotte, North Carolina, USA, presented information on the GORE Septal Occluder device, early clinical trial data, and experience with using the device for closure of ASDs and PFOs.

Similar to its earlier version—the GORE HELEX Septal Occluder—the design of the GORE Septal Occluder maintains a number of advantages. Both devices are soft and conformable, have a flattened profile, are easily repositioned, and include a retrieval cord concept.

Additional advantages of the new design include an improved delivery system for ease of use and a 5-wire design that provides enhanced disc conformability for rapid closure.

Early clinical data from a number of international trials show a high level of technical success and a high percentage of occlusion rates with the use of the device for closure of both PFO and ASD [Grohmann J et al. Catheter Cardiovasc Interv 2014; Smith B et al. Catheter Cardiovasc Interv 2014; Nyboe C et al. Catheter Cardiovasc Interv 2013].

Dr. Paolillo provided further early evidence of the highly technical success and closure rates with the new device from his experience at the Levine Children's Hospital. Since the first implant in January 2013, 22 devices have been implanted: 19 in an ASD trial and 3 in a PFO trial. Current outcomes show technical success with all 3 devices in the PFO trial with immediate complete closure and technical success in 95% (19 of 20 attempts) of the ASD trial with 100% closure by 1 month. He noted that the ASD trial included patients with multifenestrated defects and those with deficient retroaortic tissue.

Further evidence is expected from the GORE Septal Occluder European Union Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of PFO [NCT01605851], a clinical trial that began in 2012.