The FDA’s Circulatory Systems Devices advisory panel voted seven to five on 24 April 2009 in favour of the approval of the Watchman, a device implanted in the heart using minimally-invasive techniques for closure of the left atrial appendage and that may be an alternative to warfarin therapy for the prevention of stroke in patients with nonvalvular atrial fibrillation.
The recommendation of approval came with conditions, including that implantation of Watchman (Atritech) be performed in centres with surgical backup and the creation of a physician certification programme. The panel also recommended the creation of a registry and extended follow-up of current clinical trials.
Results of the PROTECT-AF (Embolic protection in patients with atrial fibrillation) pivotal premarket study, focused on the safety and effectiveness of the Watchaman, were presented at the i2 Summit of the American College of Cardiology 2009 Scientific Sessions, March, Orlando, USA. The Watchman was associated with a reduction in haemorrhagic stroke risk vs. warfarin, and all-cause-stroke and all-cause mortality-outcomes were noninferior to warfarin.
According to a report of Heart.org, some panel members were uncomfortable with the size of the 800-patient study, and the primary efficacy endpoint. Others members were concerned about assessing the long-term safety of the data given the short-term PROTECT-AF study. Some said it was pretty hard to look at the data and say the device is safe.