The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after the FDA’s Circulatory System Devices panel recommended approval of the device earlier this year. HeartWare was approved based on data from the pivotal ADVANCE trial, in which…

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Cholesterol Trends The Centers for Disease Control issued a new report with the latest details about the prevalence of cholesterol screening and high blood cholesterol in U.S. adults. Here is their summary of the key findings: …cholesterol screening increased from 72.7% in 2005 to 76.0% in 2009, whereas the percentage of those screened who reported…

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When taking care of older patients, we often have an intuitive sense of which ones will do well after an intervention and which ones won’t. This has been termed the “foot of the bed” test, or alternately something which separates a “young 80-year old” from an “old 80-year old.”  Frailty is a syndrome defined as…

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The FDA’s Circulatory System Devices panel voted 9-2 on Wednesday to recommend approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure. The panel agreed unanimously (11-0) that the new device is effective. The panel was more divided about safety but ultimately voted  8-3 that the device…

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ADVANCE (Evaluation of the HeartWare HVAD Left Ventricular Assist Device System for the Treatment of Advanced Heart Failure) evaluated the clinical efficacy of a novel small centrifugal flow pump as a bridge-to-transplant. In the trial, 140 patients who received the device were compared to a contemporaneous control group of 499 similar patients who had received a commercially…

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