The WATCHMAN™ Left Atrial Appendage Closure Device with Delivery System (Watchman device) and WATCHMAN™ FLX Left Atrial Appendage Closure Device with Delivery System (WATCHMAN™ FLX device) are permanently implanted devices intended to prevent blood clots in the left atrial appendage (LAA) from entering the bloodstream. The WATCHMAN™ or WATCHMAN™ FLX device is intended to be used in patients who have atrial fibrillation (AFib) not related to heart valve disease. (non-valvular atrial fibrillation). In AFib, the two upper chambers of the heart (right and left atria) no longer contract together in a coordinated manner and the heartbeat (pulse) becomes irregular. Because the right and left atria no longer contract normally in AFib, the blood flow in the heart can be slower than normal. This change in blood flow may cause blood clots to form. During Afib, most blood clots that develop in the heart develop in the LAA. If this occurs, these blood clots can break loose, travel through the bloodstream, and block a blood vessel in the brain and cause a stroke. Approval expands the indications to include the use of these devices in patients who have non-valvular atrial fibrillation, are at increased risk for stroke, are recommended and suitable for blood-thinning medications (anticoagulation therapy), and have an appropriate reason to seek a non-drug alternative to anticoagulation therapy. In a clinical study, in 395 out of 400 (96%) patients who had WATCHMAN™ FLX device implanted were able to stop taking their blood-thinning medications after 45 days. In addition, over 92% of patients were able to stop taking blood-thinning medications after one year following the implant procedure.
