Image: The Bio2 Medical Angel catheter intended for PE prophylaxis in trauma patients, with contraindication to anticoagulation (Photo courtesy of Bio2 Medical).
The results of a pivotal study for the evaluation of a combined inferior vena cava filter and central venous catheter to prevent pulmonary embolism in critical trauma patients have been published.
The single-arm, multicenter clinical trial showed that the combined catheter resulted in a substantial reduction in clinically significant, as well as fatal cases of Pulmonary Embolism (PE), in critically ill patients.
The combined Angel Inferior Vena Cava (IVC) filter and Central Venous (CV), FDA-cleared catheter was developed by Bio2 Medical (Golden, CO, USA), and the results of the study were published in the June 29, 2017, issue of the Journal of Vascular and Interventional Radiology (JVIR). The catheter was inserted in the Intensive Care Unit (ICU), at the bedside, without fluoroscopy, and retrieved safely, before patient discharge. The study cohort included 163 critically ill patients contraindicated to anticoagulation, all with a high risk of acute PE, from 20 Intensive Care Units (ICUs) in the US.
The results indicated that the Angel Catheter prevented the occurrence of PEs in 11% (14) of 129 patients who had a pre-removal cavogram. The Angel Catheter also impacted PE-related spending reducing the cost of IVC filter removal, and the Interventional Radiology (IR) suite time needed.
Primary investigator of the study, Victor F. Tapson, MD, said, "Acute PE kills more than 100,000 Americans every year, and many more around the world. This study of a combined IVC filter/central venous catheter was the culmination of a panel of dedicated investigators with careful guidance by the FDA. The efficacy and safety of the device, simple bedside placement, and the need to remove it before discharge make it very appealing. Nearly the entire cohort had crucial, yet short-term filter needs so that discharge without a filter was preferred."