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New Device Shows Promise In Replacing Blood Thinner

Posted by Chrissie Cole
Monday, March 30, 2009 11:47 AM EST
Category: Major Medical
Tags: FDA and Prescription Drugs, Stroke, Coumadin, Warfarin, Heart Device, Atrial Fibrillation


IMAGE SOURCE: The Watchman / Atritech Inc.

The Watchman, a new device implanted in the heart to treat a common heart problem that can lead to stroke, shows promise, according to a newly released study.

The device targets a heartbeat disorder called atrial fibrillation. The current standard of treatment is Coumadin (generic name Warafin) a widely used blood thinner that prevents blood clots from forming and causing strokes. But, these drugs are known to be cumbersome because patients must be closely monitored when on the drug and if taken in excess, severe bleeding and death may result.

Atrial fibrillation (AF) is a disorder that affects as many as 2.2 million Americans. During AF, the heart’s two small upper chambers (the atria) spasms and beats improperly. This condition can cause blood to stagnate and form clots in an area of your heart called the left atrial appendage.

If a piece of blood clot in the atria leaves the heart and becomes stuck in an artery in the brain, a stroke is the result. An estimated 15 percent of strokes occur in people with atrial fibrillation.

The study findings, which show the Watchman was just as effective as the drug, was presented at the American College of Cardiology's annual conference in Orlando, Florida over the weekend. However, research also showed there were safety risks as well.

In the PROTECT AF study, researchers studied 707 patients with atrial fibrillation. Patients were separated into two randomized groups – one group was made up of 463 patients that were implanted with the device and the other 244 patients were treated with the drug warfarin.

The results were 15 strokes and 17 deaths in the group with the device and 11 strokes and 15 deaths in the group that took Warfarin.

Doctors believe the complications associated with the device – most of which are related to implantation – will lessen over time as they become more experienced with inserting the device.

In August, Aritech Inc., the maker of The Watchman, filed a U.S. application with the FDA seeking marketing approval for the device. On April 23, an FDA advisory panel is expected to review the product.

How the Watchman Works

The Watchman is an expandable cage designed to keep blood clots that form in the left atrial of the heart from entering the blood stream and potentially causing a stroke.

The device – which varies from large as a penny to a half-dollar - is made of materials that are common to many medical devices. The Watchman is designed to be permanently placed just behind or at the opening of the left atrial appendage.

The study was funded by Artitech Inc. #

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