Cook Medical, a cardiovascular device company, is engaged in the Cook Inferior Vena Cava Filter (CIVC) study and the PRESERVE study to provide additional data on the safety and effectiveness of its inferior vena cava filters.
The CIVC study will collect additional safety and effectiveness data on Cook Medical’s permanent and retrievable filters.
The study will add to the company’s existing clinical data on its commercially available IVC filters. This includes three previous studies including over 1,300 patients treated with Cook IVC filters.
In addition, the study will address the safety concerns expressed in the 2010 and 2014 safety communications from the US Food and Drug Administration (FDA).
Enrollment in the CIVC study, which is expected to enroll 470 patients at up to 40 international sites, began in March 2014.
Technical placement success and one-year freedom from new symptomatic pulmonary embolism, and one-year freedom from major adverse events will be the primary endpoints of the CIVC study.
The PRESERVE study will involve collaboration between Cook Medical, the Society for Vascular Surgery, the Society of Interventional Radiology, the FDA, and other filter manufacturers. This study will enroll patients in the US only.
Cook Medical Peripheral Intervention clinical division global business unit leader and vice president Mark Breedlove said that the company believes in providing physicians the data they need to make the best decisions possible when treating patients.
"In this case, these two studies should go a long way toward adding to the medical science on IVC filters," Breedlove added.