FDA panel voted to approve Boston science's watcher device

Source: China Association for the promotion of drugs December 11, 2013, Boston science company announced that the circulation system equipment group of FDA medical device Advisory Committee voted 13:1 for the benefits of left atrial appendage closure device for watchers to outweigh risks FDA will consider the panel's comments on the watcher's left atrial appendage closure device Boston expects FDA to make a decision in the first half of 2014 The results of the Advisory Committee's vote are accompanied by a review of the data from two randomized controlled clinical trials, protect AF and benefit, and a record of the cap (continuous access protocol) registry The watcher is the most studied left atrial appendage closure device and the only medical device with long-term clinical data from 2000 patients and several years' follow-up records of nearly 4900 patients in clinical trials The watcher device received the CE mark in 2005 In the United States, the watcher is a research instrument, which is only used for research and cannot be sold Original link: http://www.rttnews.com/2238334/fda-panel-voices-in-voice-of-boston-scientific-s-watchman-device-quick-facts.aspx