BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Medical is engaged in two clinical studies that will provide additional data on the safety and effectiveness of inferior vena cava (IVC) filters.
The first study, the Cook Inferior Vena Cava Filter (CIVC) study, will add to Cook’s existing clinical data on its commercially available IVC filters. This includes three previous studies including more than 1,300 patients treated with Cook IVC filters. CIVC will also address filter safety concerns expressed in the 2010 and 2014 safety communications from the U.S. Food and Drug Administration (FDA). The study’s primary endpoints will be technical placement success and one-year freedom from new symptomatic pulmonary embolism, and one-year freedom from major adverse events.
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