After a long and strange trip, developer and marketer of medical devices Boston Scientific has received green signal from the Food and Drug Administration (FDA) for its Watchman Left Atrial Appendage Closure Device in the United States. The manufacturing company was working on the device from a long time. Several times, it has been turned down by the federal agency of the United States Department of Health and Human Services.

While confirming the approval, the company said that the device is an alternative to warfarin for the reduction of thromboembolism. According to the company headquartered in Marlborough, the new device will be available at different centers across the country, where the physicians will use it in clinical studies. When the physicians are trained in its use, the device will be available in many other health centers.

As per the company, the device will be helpful in preventing strokes in patients who experience dangerous irregular heart rhythm. The device has been approved after a long strange trip. The device has a highly trouble past at the agency.

In October 2014, FDA’s Circulatory System Devices advisory panel said they didn’t think that the device could be alternative of warfarin. They said the trials showed that the Watchman wasn’t equivalent to warfarin, an anticoagulant normally used in the prevention of thrombosis. They also said that the device should be made available to protect AF patients, who did not want to take warfarin.

In 2013, the controversial PREVAIL trial removed from its featured presentation on the annual meeting of the American College of Cardiology.

Boston Scientific said the umbrella-shaped device will be helpful for heart patients who do not want to take anticoagulant drugs, such as warfarin as the drugs contain high risk of bleeding.