All percutaneous LAA closure devices, that are U.S. FDA approved for stroke prevention in individuals with atrial fibrillation is considered experimental/investigational because the safety and/or effectiveness of these devices cannot be established by the available published peer-reviewed literature.
Note: *CHADS2 score: Congestive heart failure, hypertension, age greater than 75, diabetes, stroke/transient ischemia attack/thromboembolism.
Note: ** CHA2DS2-VASc score: Congestive heart failure, hypertension, age greater than or equal to 65, diabetes, stroke/transient ischemia attack/thromboembolism, vascular disease, sex category.
Note: NVAF is defined as a rhythm disturbance that occurs in the absence of rheumatic mitral stenosis, a mechanical or bioprosthetic heart valve or mitral valve repair.
