Gore's Septal Occluder Approved for Use in REDUCE Study of PFO Closure

October 22, 2012—Gore & Associates (Flagstaff, AZ) announced that the US Food and Drug Administration has approved the use of the Gore Helex septal occluder for inclusion in the Gore REDUCE clinical study, which is evaluating the device for prevention of recurrent stroke in patent foramen ovale (PFO) patients. The company made the announcement at the TCT 2012: Transcathether Cardiovascular Therapeutics conference in Miami, Florida.

According to Gore's announcement, REDUCE is designed to demonstrate that PFO closure with the Gore device plus antiplatelet medical management reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack when compared to antiplatelet medical management alone. The prospective, randomized, multicenter trial includes up to 80 investigational sites in the United States, Europe, and Canada.

As summarized in the company's press release, the Gore septal occluder is designed to provide a treatment option with discs that are intended to conform to the anatomy of the individual patient. The device is composed of a five-wire support frame covered with a thin expanded polytetrafluoroethylene, 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 Gore REDUCE clinical study.

In Europe, the Gore device received CE Mark approval in June of 2011, for the indication of PFO and atrial septal defect closure. Lars Sondergaard, MD, who is Nordic Region Cardiology Principal Investigator for the Gore REDUCE Clinical Study, performed the first European procedures using the Gore device. “We have seen great success with the GORE septal occluder since we completed the first implant. The device provides ease of deployment and confidence through design for the patient's well being,” said Dr. Sondergaard in the company's press release.