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After receiving a non-substantially equivalent letter from the FDA last month for its skin cholesterol test, Prevu, PreMD (Toronto) has now filed a request for a second level review of the 510(k) submission. "It's been devastating in terms of impact on the company," Brent Norton, president/CEO told Cardiovascular Devices & Drugs, later acknowledging that the decision puts the company in "a tough spot."
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In an effort to better understand cardiac and other illnesses, researchers from the Université de Montréal (UdeM) said they have used a supercomputer to conduct what they believe is the largest mathematical simulation of the electrical activity of a human heart a 2-billion-element model.
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NMT Medical (Boston) in late January said it was closing its PFO/migraine trial, MIST II, citing "challenges" in patient enrollment.
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Cytori Therapeutics (San Diego) reported enrollment of the first two patients in a clinical trial using adipose-derived stem and regenerative cells in the treatment of heart attack using its device/cell treatment combination system.
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The second-generation of drug-eluting stent (DES) technology is now reality in the U.S. Medtronic (Minneapolis) in early February reported FDA approval of the Endeavor DES, making it the first in the DES 2.0 family of these devices to win marketing okay in the U.S.
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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).
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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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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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Cardiva Medical; ev3; LifeSync; NewCardio; Stereotaxis
