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New FDA-approved device lowers stroke risk

Margaret Cienki, an 80-year-old New Yorker, is minutes away from getting a new device that her physician says will lower her risk for stroke.

"I was advised it would be very good for me," Cienki told CBS News. "I'm ready for whatever has to be done."

Cienki has atrial fibrillation, a condition that causes irregular and often rapid heart beat, most commonly due to poor blood flow. Patients with atrial fibrillation are at five times greater risk of stroke, and are more likely to have a serious stroke that can be fatal or cause irreversible neurological damage. Approximately half of all stroke patients with atrial fibrillation will die or be left with significant disability.

Cienki's doctor recommended she try a device that was just approved by the U.S. Food and Drug Administration. The device, called the Watchman, is a catheter-delivered heart implant. It closes around the left atrial appendage of the heart to prevent the migration of blood clots and therefore reduce stroke risk in patients with atrial fibrillation. This site is significant because research has found that more than 90 percent of strokes arise from clots that form in the left atrial appendage.

With the device in place, "any clots that would form there can't travel to the brain and cause a stroke," Dr. Vivek Reddy, professor of cardiology at the Mount Sinai Hospital, told CBS News.

Surgeons at the Mount Sinai Hospital implanted the parachute-shaped device through a vein in Cienki's leg. The surgery is minimally-invasive and only takes about 45 minutes. Doctors say recovery is fairly quick. Cienki went home the next day.

The Watchman was approved by the FDA following a clinical trial on more than 3,300 patients. The device is registered in 75 countries and there are more than 10,000 patients worldwide who have received the implant.

Research shows the Watchman is so effective that a patient can actually stop taking blood thinners. That's a relief for Cienki and her family. Though blood thinners do significantly reduce stroke risk, they come with their own set of problems.

"Elderly patients, when they are at risk for falling, of course they can hurt themselves badly if they are on blood thinners," explained Reddy.