Cook Medical Begins Studies of Inferior Vena Cava Filters

June 2, 2014—Cook Medical announced that the company is engaged in two clinical studies that will provide additional data on the safety and effectiveness of inferior vena cava (IVC) filters.

The company stated that the Cook IVC Filter (CIVC) study will add to the company’s existing clinical data on its commercially available IVC filters—Günther Tulip and Celect. The company already has data from 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 US Food and Drug Administration (FDA). 

The CIVC study’s primary endpoints will include technical placement success, 1-year freedom from new symptomatic pulmonary embolism, and 1-year freedom from major adverse events. The study will collect additional safety and effectiveness data on Cook’s permanent and retrievable filters. Enrollment in the CIVC study began in March 2014. Up to 470 patients will be enrolled in up to 40 international sites.

The second study, PRESERVE, will involve collaboration between Cook, the Society for Vascular Surgery, the Society of Interventional Radiology, the US Food and Drug Administration, and other filter manufacturers. PRESERVE will enroll patients in the United States only, advised the company.