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, according to the firm. CIVC will also address filter safety concerns expressed in 2010 and 2014 safety communications from the U.S. Food and Drug Administration (FDA). The study's primary end points will be technical placement success, one-year freedom from new symptomatic pulmonary embolism, and one-year freedom from major adverse events.
CIVC will collect additional safety and effectiveness data on Cook's permanent and retrievable filters. Enrollment in the CIVC study began in March 2014, and up to 470 patients at as many as 40 international sites will be enrolled, Cook said.
The second study, Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE), will involve collaboration between Cook, the Society for Vascular Surgery, the Society of Interventional Radiology, the FDA, and other filter manufacturers, according to the vendor. Only U.S. patients will be enrolled in the study.
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