CardioExchange Archive

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, […]

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November 3rd, 2014

AF Patients at Increased Risk for Silent Strokes

Larry Husten, PHD

The increased risk of stroke in people with atrial fibrillation (AF) is well known, and this stroke risk is, of course, linked to an increased risk of cognitive impairment and dementia. Less well known is that people with AF have an increased risk for cognitive impairment independent of their stroke risk. Now a new study […]

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October 31st, 2014

FDA Advisory Panel Gives Tepid Support to New Anticoagulant

Larry Husten, PHD

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban (Savaysa). The outcome will likely result in a drug that will be on the market, but that few physicians will prescribe until further studies are performed. Edoxaban will almost certainly become the fourth new oral anticoagulant (NOAC) to […]

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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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July 23rd, 2014

More Questions Raised About Dabigatran

Larry Husten, PHD

Once again, dabigatran (Pradaxa) has raised the wrath of the critics. Several articles (see here, here, and here) and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The […]

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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 […]

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February 6th, 2014

First-Ever Guidelines Issued on Stroke Prevention in Women

Nicholas Downing, MD

The American Heart Association and American Stroke Association have issued the first stroke-prevention guidelines that focus on women’s unique risks. Among the recommendations: Pregnant women with chronic hypertension or a history of pregnancy-related hypertension should take low-dose aspirin, beginning at 12 weeks’ gestation, to reduce pre-eclampsia risk. Preeclampsia is a risk factor for stroke later in life, […]

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January 28th, 2014

Problems Persist Despite Gains in Oral Anticoagulant Use

Larry Husten, PHD

Although significant progress has been made in recent years, a new survey from the European Society of Cardiology finds that there are still too many atrial fibrillation patients who are not taking the best medications to reduce their elevated risk for stroke. Many elderly patients are not receiving oral anticoagulants — either traditional warfarin or […]

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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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December 5th, 2013

Large Study Finds Favorable Risk-Benefit Profile for the New Anticoagulants

Larry Husten, PHD

A very large new meta-analysis finds a favorable risk-benefit for the new oral anticoagulant drugs in the setting of atrial fibrillation. The findings, published online in the Lancet, were remarkably consistent for all four of the new agents which have been fighting to replace warfarin, which was the only oral anticoagulant available for decades until the arrival of […]

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