The United States Food and Drug Administration approved the long pending Watchman device developed by Boston Scientific Corporation (NYSE:BSX). The revolutionary surgical device is instrumental in prevention of strokes. The company has been attempting to get it approved for 6 years now. Finally, with the sanction, it can be now sold in the open market all across the country.
Slow Pace to Improve
Boston Scientific is based in Marlborough, Massachusetts, has been having a tough time recently on account of its previous devices that include pacemakers and implanted defibrillators not getting the anticipated market response. With the introduction of the Watchman device, the company expects that its revenues will increase by almost $500 million, greatly boosting its performance and satisfying its stakeholders.
The FDA Hitch
There is one drawback however, over the last 6 years that was pending before the FDA, a number of alternate solutions have emerged to tackle the same problem. The reasons cited by the FDA for not approving this device earlier were that they were not completely convinced about its effectiveness and safety. They were initially of the opinion that it could lead to complications during the process of being implanted in the body.
The Huge Advantage of the Device
The Watchman device is mainly used in patients, with irregular heartbeats that can lead to a stroke. There is another blood thinning drug that produces the same benefit to these patients and was the preferred option for a long time till Boston Scientific finally managed to convince the FDA of its additional advantages. Sometimes, the blood collects in the heart and can form clots that will flow through the body; however, the blood vessels or capillaries in the brain region are very minute and can easily get blocked, with these clots and result in a stroke.
The Watchman prevents the collection of blood by sealing off the area near the left atria and thereby prevents the formation of clots. The Senior Vice President of Boston Scientific Corporation (NYSE:BSX) was excited that they finally managed to convince the FDA of the importance of the device in dealing, with heart disorders.
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