CardioExchange Archive

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 […]

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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 […]

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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 […]

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January 22nd, 2013

How Will You PROTECT Your Patients with Nonvalvular Afib?

Eiman Jahangir, MD

For which patients is the Watchman left-atrial appendage closure device a better alternative to warfarin and other anticoagulant medications?

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