Noticias

Noticias

  • Título: Cook Medical Begins Studies of Inferior Vena Cava Filters
  • Fecha: 02-06-2014

  • Bloomington, Ind., — Cook Medical is engaged in twoclinical studies that will provide additional data on the safety and effectivenessof inferior vena cava (IVC) filters.

    The first study, theCook Inferior Vena Cava Filter (CIVC) study, will add to Cook’s existingclinical data on its commercially available IVC filters. This includes threeprevious studies including more than 1,300 patients treated with Cook IVCfilters. CIVC will also address filter safety concerns expressed in the 2010and 2014 safety communications from the U.S. Food and Drug Administration(FDA). The study’s primary endpoints will be technical placement success andone-year freedom from new symptomatic pulmonary embolism, and one-year freedomfrom major adverse events.

    CIVC will collectadditional safety and effectiveness data on Cook’s permanent and retrievablefilters. Enrollment in the CIVC study began in March 2014. Up to 470 patientsat up to 40 international sites will be enrolled in the study.

    The second study, thePRESERVE study, will involve collaboration between Cook, the Society forVascular Surgery, the Society of Interventional Radiology, the FDA, and otherfilter manufacturers, and will enroll patients in the US only.

    “Cook believes inproviding physicians the data they need to make the best decisions possiblewhen treating patients. In this case, these two studies should go a long waytoward adding to the medical science on IVC filters,” said Mark Breedlove, vicepresident and global business unit leader for Cook Medical’s Peripheral Intervention clinical division.



  • Fuente: endovascular.es