The Institute of Medicine (IOM) has released a report highly critical of the FDA’s 510(k) medical device clearance process and called on the FDA to develop “a new framework that used both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices.” The…

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AstraZeneca will be charging a premium price for its new antiplatelet drug ticagrelor (Brilinta). Wall Street analyst Timothy Anderson reports that the daily treatment cost for the drug will be $7.24 on a wholesaler acquisition cost (WAC) basis, which is approximately 20% higher than the daily cost of $6.08 for clopidogrel (Plavix) and about 25%…

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A phase III trial has yielded mixed results for an experimental implantable device that uses baroreflex activation therapy (BAT) to treat resistant hypertension. The article on the manufacturer-funded Rheos Pivotal Trial, by John Bisognano and colleagues, has been published online in the Journal of the American College of Cardiology. The Rheos device was implanted in…

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Although coronary and cerebrovascular disease usually receive equal weight when family history is assessed as a risk factor, a new study suggests that family history may play a more important role in MI and ACS than in stroke or TIA. In an article published in Circulation: Cardiovascular Genetics, Amitava Banerjee and colleagues report the results…

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Current risk prediction models classify diabetes as equivalent to established cardiovascular disease. Now, a new report from the Women’s Health Study and the Physician’s Health Study II suggests that adding HbA1c measurements to the model can improve risk prediction and lead to downward classification of some diabetics. In a paper published in Archives of Internal…

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A large phase 3 trial of an investigational factor Xa inhibitor, when added to antiplatelet therapy in ACS patients, was stopped early because of bleeding complications.

The FDA has issued an update on dronedarone (Multaq, Sanofi Aventis), and the European Medicines Agency (EMA) has updated its reviews of dronedarone and 2 other drugs that also have been the subject of recent controversies: pioglitazone (Actos and other names, Takeda) and varenicline (Champix, Pfizer). The FDA and dronedarone: The FDA issued a safety communication…

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Measurement of the maximum intima–media thickness (IMT) of the internal carotid artery (CA) can modestly improve cardiovascular risk prediction, according to a new study published in the New England Journal of Medicine. Joseph Polak and colleagues measured the mean IMT of the common CA and the maximum IMT of the internal CA of 2965 subjects…

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The FDA Circulatory Systems Devices Panel has given a strong vote of support in favor of the Sapien Transcatheter Heart Valve (THV) for use in patients with inoperable severe aortic stenosis and with no comorbidities precluding benefit from correction of the stenosis. By large majorities, the panel voted that the procedure was safe (7-3), that…

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With the FDA approval, will you be using this drug in your practice?