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Left Atrial Appendage Closure Studies: FDA Offers Tips

The clinical path toward FDA approval of a left atrial appendage closure system for preventing stroke in atrial fibrillation patients has not been simple so far, informing the agency’s current expectations.

Clinical trials of left atrial appendage closure systems for stroke prevention should aim to show that a patient can come off oral anticoagulation therapy within 45 days of treatment, while demonstrating a solid safety profile out to two years, according to FDA.

There are yet no LAA closure devices approved for preventing stroke in atrial fibrillation patients in the U.S. Boston Scientific’s minimally invasive Watchman appears furthest along, with PMA approval expected...

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