ATS To Enter U.S. Tissue Valve Market In 2009 With 3f Aortic Device
This article was originally published in The Gray Sheet
Executive Summary
ATS Medical will bring its mechanical heart valve brand power to the U.S. tissue valve market with the launch of the 3f aortic bioprosthesis early next year
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ATS Medical Seeks FDA Go-Ahead For Two-Arm Enable Valve Study
ATS Medical will submit an investigational device exemption application to FDA by year-end for a planned two-arm U.S. pivotal study of its 3f Enable sutureless valve, CEO Mike Dale said during a March 2 panel at the RBC Capital Markets Healthcare Conference in New York City
ATS Medical Seeks FDA Go-Ahead For Two-Arm Enable Valve Study
ATS Medical will submit an investigational device exemption application to FDA by year-end for a planned two-arm U.S. pivotal study of its 3f Enable sutureless valve, CEO Mike Dale said during a March 2 panel at the RBC Capital Markets Healthcare Conference in New York City
Research In Brief
Cardiac troponin tests: Early diagnosis of acute myocardial infarction could be substantially improved with the addition of a sensitive cardiac troponin assay, according to two studies published in the Aug. 27 issue of the New England Journal of Medicine. In an ongoing study led by Tobias Reichlin, University Hospital, Basel, Switzerland, et al., sensitive cardiac troponin assays were significantly more accurate than a standard assay in blood samples from 718 unselected patients who presented with symptoms of AMI. The trial used four sensitive assays--Abbott's Architect Troponin I, Roche's High-Sensitive Troponin T, Roche's Troponin I and Siemens' Troponin I Ultra--and the Roche Troponin T standard assay. The negative predictive value of the sensitive tests ranged from 97% to 99%, meaning the sensitive assays "may make it possible to reliably rule out the diagnosis of acute myocardial infarction in many patients on the basis of the initial measurement," the authors write. The second study, led by Till Keller, Johannes Gutenberg University of Mainz, Germany, compared Siemens' Troponin I Ultra to a standard assay and traditional markers of cardiac necrosis in 1,818 unselected patients with new-onset chest pain. The accuracy of the Siemens test was 96%, versus 85% with the standard assay