US FDA approves Boston Scientific's Watchman Left Atrial Appendage Closure Device

Boston Scientific Corp said the US Food and Drug Administration yesterday approved its device to prevent stroke in patients with irregular heart rhythm called atrial fibrillation.

The Watchman Left Atrial Appendage Closure Device, relieves heart patients from dependence on anticoagulant drugs, such as warfarin, that carry a high risk of bleeding.

Boston Scientific had been working on the development of the device for well over a decade and had been turned down by the FDA on a number of occasions.

The company claims Watchman device was indicated as an alternative to long-term warfarin use in order to reduce thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism.

To be eligible to use the device, patients must be ''deemed by their physicians to be suitable for warfarin'' and to have an ''appropriate rationale'' for preferring the device to warfarin.

According to Boston Scientific, the device would be first available at centres where it had been used in clinical studies. Availability would be more widespread as physicians were trained in its use.

The Watchman had had a long and highly troubled history at the FDA. Most recently, last October, the devise received a very cautious endorsement from the FDA's Circulatory System Devices advisory panel.

The trials supporting the device, Protect AF and Prevail, had clearly shown that Watchman was not equivalent to warfarin, the current standard of therapy. However, the FDA felt that the device should be made available to atrial fibrillation patients who were eligible for, but did not want to take warfarin.