March 14th, 2015
FDA Approves Watchman Left Atrial Appendage Closure Device for AF
Larry Husten, PHD
The FDA has approved Boston Scientific’s long-delayed Watchman Left Atrial Appendage Closure Device. According to the company, the Watchman is indicated as an alternative to long-term warfarin therapy for the reduction of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism. Although an alternative to warfarin, […]
October 9th, 2014
FDA Panel Gives Cautious Endorsement to Novel Boston Scientific Device
Larry Husten, PHD
The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use. The panel wrestled throughout […]
June 18th, 2014
Yet Another Delay for Boston Scientific’s Watchman Device
Larry Husten, PHD
Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said […]
December 12th, 2013
FDA Panel Gives Support to Left Atrial Appendage Closure Device
Larry Husten, PHD
The FDA’s Circulatory System Devices Panel yesterday gave a vote of confidence to Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients. By a large majority, the panel agreed that the device was effective, that it was safe, and that the benefits outweighed the risks. In each case the […]
May 10th, 2013
Encouraging 4-Year Results for Boston Scientific’s Watchman Device in AF Patients
Larry Husten, PHD
Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation (AF) patients were presented yesterday at the Heart Rhythm Society meeting in Denver. Previously the main results of the trial, published in the Lancet, demonstrated that the Watchman was noninferior to warfarin, but the total number of events […]
March 9th, 2013
Following an Embargo Break PREVAIL Trial Won’t be Presented at ACC
Larry Husten, PHD
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters. The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the […]
January 22nd, 2013
Trials of Niacin and AF Device Will Headline American College of Cardiology Program
Larry Husten, PHD
Two big trials will highlight this year’s American College of Cardiology (ACC) meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific’s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation (AF). Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. The […]
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