In the year and a half after its approval the Watchman left atrial appendage closure device was successfully implanted 95.6% of the time, or more than 3,600 times out of a total of 3,822 consecutive cases. The finding comes from procedural data collected by Boston Scientific and presented at TCT by Vivek Reddy (Mt. Sinai)…
CMS Proposal Would Plug Up Watchman Reimbursement
November 11, 2015 by Leave a Comment
Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…
What A Long Strange Trip It’s Been: FDA Approves Watchman Device From Boston Scientific
March 13, 2015 by Leave a Comment
Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions. … Click here to…
Medtronic And Boston Scientific Plan To Resume Blood Pressure Trials This Year
February 19, 2015 by Leave a Comment
Medtronic and Boston Scientific have announced plans to start phase 2 clinical trials this year for their updated renal denervation catheters. The once promising new technology is intended to treat hypertension unresponsive to drug therapy. The failure last year of Medtronic’s Symplicity HTN-3, the first large pivotal trial to rigorously test renal denervation, sent manufacturers back to their…
FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device
October 8, 2014 by Leave a Comment
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. … Click here…
Novel Boston Scientific Device Headed For Another Rough FDA Panel
October 7, 2014 by Leave a Comment
On Wednesday Boston Scientific’s Watchman device will once again appear before the FDA’s Circulatory System Devices advisory panel. The Watchman is a novel catheter-delivered left atrial appendage closure device which is intended to be used in place of chronic warfarin therapy to lower the risk of stroke in people with atrial fibrillation. It has been under development for more than…
Yet Another Delay For Boston Scientific’s Watchman Device
June 17, 2014 by Leave a Comment
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…
The Uncertain Future Of A Once Highly Promising Device For Lowering Blood Pressure
April 14, 2014 by Leave a Comment
Following the spectacular crash and burn of the Symplicity HTN-3 trial at the American College of Cardiology two weeks ago, the future of renal denervation (RDN)– the once highly promising catheter technology that many thought would cure resistant hypertension– appears in doubt. Although the device has not been approved in the US– and will not be approved without…
FDA Panel Gives Support To Novel Stroke Prevention Device From Boston Scientific
December 12, 2013 by Leave a Comment
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…
Boston Scientific May Face A Tough FDA Panel
December 10, 2013 by Leave a Comment
On Wednesday the FDA’s Circulatory System Devices Panel will once again review Boston Scientific’s Watchman left atrial appendage closure device for the prevention of stroke in atrial fibrillation patients (click here for the meeting materials). The panel will be the latest chapter in the long and contentious story of the Watchman. In 2010 the FDA issued a complete response…
Stents Lose In Comparisons With Surgery And Medical Therapy
December 3, 2013 by Leave a Comment
Despite the enormous increase in the use of stents in recent decades, there is little or no good evidence comparing their use to the alternatives of CABG surgery or optimal medical therapy in patients also eligible for these strategies. Now two new meta-analyses published in JAMA Internal Medicine provide new evidence that the alternatives to PCI remain attractive…
New Subcutaneous ICD Said To Pose ‘Existential Crisis’ For Older ICDs
August 26, 2013 by Leave a Comment
Last year the FDA approved Boston Scientific’s subcutaneous ICD, the first ICD that can defibrillate the heart without using leads threaded to the heart through the blood vessels. Those leads are the source of many sophisticated pacing features in today’s ICDs, but they are also the main source of ICD-related complications, and, in several well-publicized…
Encouraging 4 Year Results For Watchman Device In AF Patients
May 10, 2013 by Leave a Comment
Encouraging long-term results from the PROTECT AF trial comparing the Watchman left atrial appendage closure device to warfarin in atrial fibrillation 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…
Following An Embargo Break PREVAIL Trial Won’t Be Presented At ACC
March 9, 2013 by 2 Comments
UPDATED–The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the Watchman left atrial appendage closure device, just got even more complicated. This morning, after the trial’s sponsor, Boston Scientific, prematurely distributed to investors a press release summarizing the results of the trial, the ACC announced that…
Trials Of Niacin And Atrial Fibrillation Device Will Headline American College Of Cardiology Program
January 22, 2013 by Leave a Comment
Two big trials will highlight this year’s American College of Cardiology 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. Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. Read my…
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