Researchers present Saturday at the American College of Cardiology Conference in Orlando, Florida said a new device to treat atrial fibrillation, a condition that can lead to stroke, showed promise in testing, but with some risks as well. Atrial fibrillation is currently afflicting more than 2 million Americans putting their lives at risk.

 

The device, called the Watchman, and made by Atritech Inc. reduced the risk of stroke and cardiovascular death by 32 percent compared to warfarin, a widely used blood thinner that carries a high bleeding risk. However, the Watchman had twice as many procedure-related complications, with most of them occurring when placing it in the heart, but these complications got better in time as doctors improved their technique.

 

“The take-home message is that although there are complications associated with implantation of the device, patients can avoid the need for chronic warfarin therapy, with all its attendant risks.” Dr. David Holmes, professor of medicine at the Mayo Graduate School of Medicine in Minnesota, said.

 

The findings were based on a study of 707 patients with atrial fibrillation, a condition that can lead to blood clots and stroke. The condition had been treated with warfarin or in some severe cases with open heart surgery. But, thanks to the new study, patients developing atrial fibrillation now have a chance to avoid strokes, and thus death.

 

 Atritech filed a US application to the Food and Drug Administration in August seeking marketing approval for the Watchman, including the results of the study presented at the conference. An FDA advisory panel will review the product on April 23.