First Quarter Earnings in Brief
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences: FDA has formally accepted the company's response to a February warning letter citing quality system deviations, including complaint handling, documentation and training issues, at its Irvine, Calif., facility and will not defer approval of any pending PMA or export certificates for products manufactured there, the company announces during its April 23 earnings call (1"The Gray Sheet" Feb. 26, 2007, In Brief). For the first quarter of 2007, ended March 31, Edwards income was $33.2 million, down from $45.9 million in the first quarter of 2006. However, earnings were up 2.9% to $264.1 million. Heart valve sales grew 3.5% to $129.5 million led by sales of Magna tissue valve products outside the United States. Critical Care sales grew 12.1% to $90.9 million led by the FloTrac pressure monitoring system. Cardiac Surgery Systems sales were down about 28% to $16.8 million due primarily to Edwards' departure from the perfusion and transmyocardial revascularization markets..
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