FDA Approves LAA Closure Device Study


November 3, 2010

November 3, 2010 – The first patient has been enrolled into a study comparing a left atrial appendage (LAA) closure device to warfarin therapy in those with atrial fibrillation. The PREVAIL study will look at Atritech’s Watchman LAA closure device.

Central Baptist Hospital in Lexington, Ky., enrolled the first patient.

"We are pleased to have enrolled the first patient in the PREVAIL study,” said Gery Tomassoni, M.D., director of research at Central Baptist Hospital. “Our experience in the PROTECT AF study was very positive. We look forward to being a major enrolling center in this study and being able to offer an alternative to long term anticoagulation therapy to our patients."

The Watchman device is designed to keep harmful sized blood clots from entering a patient's blood stream, potentially causing a stroke. Patients with atrial fibrillation are at a greater risk of having a stroke due to the formation of clots in an area of the heart called the left atrial appendage (LAA). Atrial fibrillation occurs when the upper chambers of the heart beat too rapidly. Typically these patients require blood-thinning medications such as warfarin to prevent these clots from forming in the heart.

The PROTECT AF clinical study compared the Watchman to the current standard of care, warfarin, in patients with non-valvular atrial fibrillation. The device received Circulatory Panel Approval in the United States in April 2009, but the U.S. Food and Drug Administration (FDA) requested a smaller confirmatory study be conducted before granting full approval.

The Watchman is commercially available in Europe and other major areas outside of the United States.

For more information: http://www.atritech.net