The WATCHMAN Left Atrial Appendage (LAA) Closure Device for Atrial Fibrillation
WATCHMAN LAA Closure Technology – P130013
- Premarket Approval (PMA) Application Filed: May 14, 2013
- On August 7, 2013, FDA granted priority review because the device affects a condition that is life-threatening or irreversibly debilitating and there is no approved alternative.
- PMA Approval: March 13, 2015
Indications for Use
The WATCHMAN Device is indicated to reduce the risk of thromboembolism from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation who:
- Are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc1 scores and are recommended for anticoagulation therapy;
- Are deemed by their physicians to be suitable for warfarin; and
- Have an appropriate rationale to seek a non-pharmacologic alternative to warfarin, taking into account the safety and effectiveness of the device compared to warfarin.
FDA Approval Information
- FDA Approval Information for Watchman
- Summary of Safety and Effectiveness Data (SSED)
What Is Watchman Device?
The following video describes a procedure for percutaneous placement of the WATCHMAN Left Atrial Appendage (LAA) Device.
The WATCHMAN is a nitinol device designed to be permanently implanted at, or slightly distal to, the opening of the left atrial appendage (LAA) to trap blood clots before they exit the LAA, preventing thromboembolic stroke.