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Cytori Therapeutics (San Diego) reported receiving its first orders from Europe and Asia for Celution 800 Systems. Eleven Celution 800 Systems and related CT-805 single-use consumables were ordered by Cytori's distributors MBA Grupo, which covers Spain, Italy, and Portugal, and Astrea International, which covers Singapore. Cytori says the first devices are to be delivered this quarter.
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Heart drugs aren't all that controversial, but the approval of the heart failure drug BiDil raised some interesting questions. And its future is currently in doubt.
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diaDexus (San Francisco) has received FDA clearance for a new automated version of its PLAC Test.
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The American Heart Association (AHA; Dallas) recently reported that U.S. deaths from heart disease and stroke dropped about 25% from 1999 to 2005, five years ahead of goals.
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The most common way to investigate the functions of miRNAs is to inhibit them one at a time.
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Cardiva Medical; ev3; LifeSync; NewCardio; Stereotaxis
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CryoLife's (Kennesaw, Georgia) decellularized replacement heart valve used to replace diseased, damaged, malformed or malfunctioning pulmonary valves in early February received FDA 510(k) clearance. Children who face multiple surgeries for congenital heart defects will likely be the most significant beneficiaries of the new valves, according to the company, by potentially reducing the number of surgeries they must have over a lifetime.
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FDA has asked for more information and clarification regarding a pre-market approval application for the ATS 3f aortic bioprosthesis from ATS Medical (Minneapolis), a company that makes products for cardiac surgery.
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According to a paper published in the American Heart Journal (2008; Vol. 155, Issue 1: 128-132), the Bio-Engineered R stent from OrbusNeich (Hong Kong), is feasible and safe for use in acute myocardial infarction (AMI).