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The WATCHMAN FLX Device is indicated to reduce the risk of thromboembolism, including stroke, in patients with non-valvular atrial fibrillation (AF) who are at risk for stroke and not candidates for oral anticoagulation (OAC). The device is implanted in the left atrial appendage (LAA) and is designed to occlude the LAA to reduce the risk of thromboembolism. The device is intended to be used in patients who have an increased risk of stroke and systemic embolism based on a CHA 2DS2-VASc score of ≥2, and who are deemed by their physician to be suitable for the WATCHMAN FLX Device based on an assessment of the patient’s risk of bleeding.
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