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Advisers to the U.S. Food and Drug Administration on Tuesday backed an approval for Abbott Laboratories' heart valve repair device that is designed for patients who are at risk of complications or ...
(Reuters) -Abbott Laboratories said on Tuesday the U.S. FDA has approved its heart valve repair device for patients with a potentially fatal heart disease, just months after rival Edwards ...
Conducted at 31 medical centers in the U.S., Canada and Europe, the study followed 1,014 eligible patients implanted with the Trifecta valve between 2007 and 2009 as part of a U.S. Food and Drug ...
[31] [32] It was the first aortic valve device to receive FDA approval, in November 2011 for use in inoperable patients and in October 2012 for use in patients at high surgical risk. [33] The device is effective in improving functioning in patients with severe aortic stenosis.
The Food and Drug Administration Modernization Act of 1997 (Public Act 105-115) [4] amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create and operate a public information resource, which came to be called ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational ...
Cannon A wave. Cannon A waves, or cannon atrial waves, are waves seen occasionally in the jugular vein of humans with certain cardiac arrhythmias.When the atria and ventricles happen to contract simultaneously, the right atrium contracts against a closed tricuspid valve, resulting in back pressure into the venous system that can be seen in the jugular venous pulse as a high-amplitude "cannon ...
The healthcare giant can still deliver the results and performance it has in the past. Abbott should also maintain its dividend, which yields about 2.1%. The company has been increasing payouts ...
She grew Evalve Inc. until the Abbott acquisition in 2009, and led a trial of 600 patients that revealed those using MitraClip reduced their hospitalizations in half and deaths by 38 percent. [8] MitraClip was first implanted in 2003, obtained CE marking in Europe in 2008, and approved by the U.S. Food and Drug Administration in 2013. [9]