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FDA Approves New Drug-Coated Balloon to Open Blocked Leg Arteries (5 Jan 2015)

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Medtronic said today that it had received approval from the FDA to market its IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication. The new DCB uses the anti-proliferative drug…

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An Examination of MR CLEAN (24 Dec 2014)

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Rory J Spiegel, MD

Rory Spiegel examines why the MR CLEAN trial of interventional therapy for acute ischemic stroke succeeded where its predecessors failed.

Avatar of Larry Husten, PHD

Dutch Trial Gives Support to Thrombectomy for Ischemic Stroke (17 Dec 2014)

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A large new trial provides the first substantial evidence that thrombectomy may be beneficial in patients with acute ischemic stroke. Previous thromboectomy trials have been disappointing; some experts have speculated this may be due to the use of early-generation devices, long treatment delays, and difficulties in recruiting suitable patients into the trials. The Multicenter Randomized…

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Avatar of Larry Husten, PHD

Economic Study Finds VTE Prophylaxis with Low-Molecular-Weight Heparin Cost Effective (3 Nov 2014)

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Critically ill patients in the hospital are at high risk for developing venous thromboembolism (VTE). The 2011 PROTECT trial compared the two most common drug strategies used to prevent VTE — unfractionated heparin (UFH) and dalteparin, a low-molecular-weight heparin (LMWH) —  and found no difference between the two groups in the primary endpoint of the trial, leg deep-vein thrombosis….

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Avatar of Larry Husten, PHD

First Drug-Coated Balloon Approved by FDA for Leg Blockages (13 Oct 2014)

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The FDA today announced that it had approved for use in the U.S. the first drug-coated angioplasty balloon catheter to re-open blocked arteries in the superficial femoral and popliteal arteries. The Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB) is manufactured by CR Bard and has been available in Europe since 2012. “Peripheral artery disease can be quite serious….

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Avatar of Larry Husten, PHD

Lower Rate of Microvascular Complications in Statin Users Who Develop Diabetes (9 Sep 2014)

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In recent years, the medical community has become increasingly aware that taking statins can result in slightly higher glucose levels, and this can lead to a diagnosis of diabetes in a small but statistically significant number of people. But it has been unclear whether the diagnosis of diabetes in people taking statins also places them…

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FDA: Risk for Venous Thromboembolism with All Testosterone Products (23 Jun 2014)

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The FDA is requiring an expanded label change to all approved testosterone products to warn of the increased risk for venous thromboembolism. Labels currently address the risk for clots associated with polycythemia caused by testosterone treatment. The action follows reports of blood clots in testosterone users unrelated to polycythemia. The agency says the warning is…

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Vena Cava Filters Reduce Pulmonary Emboli But Increase VTE Recurrence Tenfold (6 Mar 2014)

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Inferior vena cava filters seem to offer protection against death from pulmonary embolism when compared with anticoagulant therapy, but they have no significant effect on all-cause mortality. In addition, the filters are associated with higher rates of recurrent venous thromboembolism, according to an article in the Journal of the American College of Cardiology. Researchers examined…

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Stent Remains Available Despite Trial Showing Dangers (24 Jan 2014)

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A leading critic says that the FDA has been remiss for not removing a stent from the market although strong evidence exists that its use leads to more deaths and strokes. The Wingspan intracranial stent, manufactured by Stryker Neurovascular, was approved in 2005 by the FDA through the humanitarian device exemption (HDE) for the rare…

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Nontechnical Skills Matter in the Cardiac Operating Room (9 Sep 2013)

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Joyce Ann Wahr, M.D. and Harlan M. Krumholz, MD, SM

Joyce A. Wahr discusses the importance of teamwork and communication in performing cardiac surgery, as described in a new AHA scientific statement.