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October 5, 2010 – A U.S. clinical study evaluating the CrossBoss and Stingray catheters in treating chronically occluded coronary arteries concluded in August and Bridgepoint Medical has asked the Food and Drug Administration (FDA) to expand the indication for the devices.

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October 4, 2010 – Germany will reimburse patients who have a left atrial appendage closure procedure in 2011. The 2011 G-DRG (German Diagnosis Related Group) catalog, recently published on the InEK website, adds the left atrial appendage closure procedure to an existing G-DRG code.

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October 4, 2010 - Johnson and Johnson has completed the acquisition of Micrus Endovascular, a developer and manufacturer of minimally invasive devices for hemorrhagic and ischemic stroke. The agreement was first announced on July 12, 2010.

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Technology

October 4, 2010 – The U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 0 in favor of approving dabigatran etexilate for stroke prevention in patients with atrial fibrillation (AFib). An estimated 2.3 million Americans have AFib, and that number is expected to more than double by 2050.

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October 4, 2010 – Long-term data from a clinical trial studying the benefits of implantable cardioverter defibrillator (ICD) therapy have been published in Circulation.

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October 1, 2010 – The Bradenton Cardiology Center is the first clinic in the United States to implant a peripheral self-expanding stent as part of the OSPREY study. The trial, which is evaluating the safety and efficacy of Terumo’s Misago stent system in the superficial femoral artery (SFA), will simultaneously enroll patients in the United States and Japan.

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October 1, 2010 – A new Medicare-reimbursable stress test module has been launched that can assess the risk of sudden cardiac arrest. The Microvolt T-Wave Alternans (MWTA) module, by Cardiac Science, integrates with the company’s Quinton Q-Stress cardiac stress systems.

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October 1, 2010 – The maker of a biodegradable stent has brought in $8.5 million during a new round of venture financing from existing investors. Arterial Remodeling Technologies (ART) now has $17 million in total investment from Matignon Technologies, Amundi Private Equity Funds and InnoBio Fund managed by CDC Enterprises.

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Feature | Dave Fornell

October 1, 2010 – The most recent clinical data from USpella, a U.S. multicenter, observational registry of patients who received percutaneous cardiac support from the Impella 2.5 device, was released at TCT 2010 last week.

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October 1, 2010 – The U.S. Food and Drug Adminstration (FDA) Center for Drug Evaluation and Research (CDER) has awarded two contracts to support the agency’s review of cardiac safety data. Both contracts were given to Mortara Instrument.

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October 1, 2010 – An early-warning system for detecting coronary occlusion has received the CE mark for commercial sale in Europe. The AngelMed Guardian System, by Angel Medical Systems, is designed to detect coronary occlusion from thrombotic events, such as plaque ruptures, and alert the patient, often before any symptoms occur.

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Technology

September 30, 2010 – New angiography navigation tools for structural heart cases were shown by GE Healthcare during last week's Transcatheter Cardiovascular Therapeutics (TCT) 2010 symposium.

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September 30, 2010 – A specialized partner program was recently launched to enable select top healthcare institutions to provide advanced training in hemodynamic support and complex patient management.

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September 30, 2010 – The U.S. Food and Drug Administration (FDA) has cleared a software interface and image segmentation system that can help simulate and evaluate surgical treatment options.

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September 29, 2010 – A new portable, arm-held ultrasound system can provide fast, easy and reliable diagnosis even in critical emergency situations. The MyLabOne, by Biosound Esaote, is lightweight and features a 12-inch, color, touch-screen display.

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