Wednesday, December 11, 2013

Watchman - Left Atrial Appendage Closure Device Wins FDA Panel's Backing

A panel of FDA advisers gave strong backing to an implantable device which was designed to reduce the risk of stroke in patients with atrial fibrillation. The Watchman device was designed and studied as an alternative to blood-thinners in preventing strokes in patients with afib.
Wachman Device delivered in the LAA
Watchman device positioned in the Left Atrial Appendage

Patients with atrial fibrillation are 5-7 times more likely to have a stroke, Every patient with afib needs to have some type of therapy aimed at reducing the risk of stroke. Most patients will take either aspirin or blood thinners. Unfortunately, some patients can't tolerate these medications or have bleeding while on it.
In patients with afib, over 90% of strokes are caused by blood clots that form in the left atrial appendage. Blood thinners prevent the formation of clots in the appendage. The Watchman device comes as a great alternative for patients with atrial fibrillation. 
The device is delivered via the femoral vein, in your leg, and advanced into your heart. It is then deployed in the left atrial appendage, completely occluding it. By occluding the appendage, the risk of strokes in patients with afib is significantly reduced. 
how is the watchman device delivered?
Implantation of the Watchman Device: device is inserted into the femoral vein and advanced into the heart. The device is then carefully deployed into the left atrial appendage, completely occluding it.

A large study conducted by Boston Scientific, called the Prevail Study, evaluated patients who were candidates for anticoagulation. The patients were randomized to either coumadin or the Watchman Device. The results were very positive. The FDA advisory committee voted 13-1 in favor of Watchman's efficacy and 13-1 in favor of the device's safety.

Jose Osorio, MD

Cardiac Electrophysiologist

St Vincent's Hospital

Birmingham, Al

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