Watching, but not waiting: vascular neurology perspective on the disparate regulatory pathways for stroke

Vascular neurologists have keenly watched the Watchman device (Atritech, Plymouth, Minnesota, USA) regulatory approval process. We are, as always, searching for additional options in the prevention and treatment of stroke to better care for our patients, and new approaches to the management of atrial fibrillation play a large part in this effort. Recently, a Food and Drug Administration (FDA) panel voted 13:1 in favor of the Watchman device for the prevention of ischemic stroke in non-valvular atrial fibrillation.1 The panelists came to this decision after reviewing data from large randomized trials that compared anticoagulation with warfarin, the standard of care at the time, with antiplatelet therapy plus occlusion of the left atrial appendage with the Watchman device.2 3 The studies found that the approach incorporating the Watchman device was non-inferior to warfarin in the prevention of stroke or systemic embolism, with an...
Source: Journal of NeuroInterventional Surgery - Category: Neurosurgery Authors: Tags: Editorials Source Type: research