FDA approves Gore Septal Occluder for use in Gore REDUCE clinical study


The US Food and Drug Administration (FDA) has approved the use of the new Gore septal occluder for inclusion in the Gore REDUCE clinical study. Gore is introducing the technology in the REDUCE study for prevention of recurrent stroke in patent foramen ovale (PFO) patients.

The study is designed to demonstrate that PFO closure with the Gore device plus antiplatelet medical management therapy reduce the risk of recurrent stroke or imaging-confirmed transient ischaemic attack (TIA) when compared to antiplatelet medical management. The prospective, randomised, multicentre, multinational trial includes up to 80 investigational sites in the USA, Europe and Canada.

The septal occluder device received CE mark in June 2011 for the indication of PFO and atrial septal defect (ASD) closure. Lars Sondergaard, Nordic region cardiology principal investigator for the REDUCE study who performed the first European procedures, said: “We have seen great success with the septal occluder since we completed the first implant. The device provides ease of deployment and confidence through design for the patient’s well being.”

The septal occluder is a next generation device that successfully integrates innovative material and design to yield a treatment option whose discs are intended to conform to the anatomy of the individual patient. The device is comprised of a five-wire support frame covered with a thin ePTFE, patch-like material. The soft, strong and conformable membrane is intended to improve closure performance, providing an open microstructure to encourage fast controlled tissue ingrowth. This structure is designed to help enhance the safety of the procedure, one of several characteristics that will be investigated in the REDUCE study.