FDA approves Boston Scientific’s Heart Device

FDA approves Boston Scientific’s Heart Device

The U.S. Food and Drug Administration (FDA) has given approval to Boston Scientific Corp.’s heart device, which tends to reduce the risk of stroke in patients with quivering hearts.

It was found that stock of Boston Scientific Corp. was trading higher by 4 percent on Monday after receiving FDA’s approval.

The FDA gave permission for the commercial sales of the Watchman left atrial appendage closure device late Friday.

The Minnesota-designed device got approval for patients whose atrial fibrillation causes a high risk of having a stroke and who are undergoing an alternative to blood-thinning warfarin drugs like Coumadin.

Boston Scientifics’ chief medical officer in rhythm management, Dr. Kenneth Stein said that they are very pleased with the label given by FDA. The label lists which group of patients can undergo Watchman therapy.

Stein said they were quite worried as they thought that FDA’s approval will limit the usage of the device for patients.

It has been told that some patients can use the device as a first-line treatment to reduce the risk of stroke if they have a valid reason to avoid blood-thinning drugs.

Patients have to be able to tolerate some level of blood-thinning medication, however, because warfarins are recommended for at least six weeks after the procedure is done.

The device label will include unusual section which will describe considerations for selecting the right patients, Stein said.

According to the American Heart Association, arterial fibrillation is an irregular heartbeat that feels like a quivering heart and affects about 2.7 million Americans.

The condition increases the risk of stroke because an irregular heartbeat can cause blood to pool in an area of the heart called the left atrial appendage, where it can form clots.

Stein said, “If there are patients who are on the drugs who are doing well, we are not pushing for device use on those patients”.