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# Gore Septal Occluder Expanded Approval
- URL: https://www.fdaweb.com/gore-septal-occluder-expanded-approval/
- Published: 2018-04-03T12:00:00.000Z
- Updated: 2026-09-14T23:57:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141139

FDA has approved a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for *patent foramen ovale* (PFO) closure to prevent recurrent ischemic strokes. The device was previously approved for closure of atrial septal defects up to 17 mm. The expanded was supported by data from the REDUCE study, which was published in the *New England Journal of Medicine* 9/2017.

Results from the study showed a statistically significant (77%) reduction in recurrent ischemic stroke in patients who underwent PFO closure with the Gore device in conjunction with antiplatelet therapy, versus those who underwent antiplatelet therapy alone, after an average of 3.4 years of follow-up, Gore says. The study also met its other primary endpoint of reducing “new brain infarct, inclusive of clinically evident and clinically silent brain infarct, through PFO closure, yielding a 49% relative risk reduction,” it adds.