Results Published for Bio2 Medical's Angel Catheter Pivotal Study
June 29, 2017—Bio2 Medical announced that the results of the pivotal study for the company's Angel catheter were published by Victor F. Tapson, MD, et al online ahead of print in Journal of Vascular and Interventional Radiology (JVIR). The study met all safety endpoints and showed that the Angel catheter demonstrated a significant reduction in clinically significant and fatal pulmonary embolism (PE). The data will be presented at the 76th annual meeting of the American Association for the Surgery of Trauma and Clinical Congress of Acute Care Surgery on September 13–16 in Baltimore, Maryland.
Bio2 Medical reported that the Angel catheter was tested in a single-arm, multicenter clinical trial in which the device was inserted bedside in the intensive care unit (ICU) without fluoroscopy and was safely retrieved from all patients before discharge. The study included 163 critically ill patients with a high risk of acute PE and contraindications to anticoagulation, with 151 (93%) critical trauma patients. In this trauma group, 129 (85%) patients had experienced spinal or head trauma, 102 (79%) of which also had intracranial bleeding. With no catheter-related blood stream infections (CRBSIs), the Angel catheter successfully averted PEs in 14 (11%) of the 129 patients with a preremoval cavogram.
Dr. Tapson, who is with Cedars-Sinai Medical Center in Los Angeles, California, is the study's Principal Investigator. He commented in the company's press release, "Acute PE kills more than 100,000 Americans every year and many more around the world. This study of a combined inferior vena cava filter (IVC)/central venous catheter was the culmination of a panel of dedicated investigators with careful guidance by the US Food and Drug Administration (FDA). The efficacy and safety of the device, simple bedside placement, and the need to remove it before discharge makes it very appealing. Nearly the entire cohort had crucial, yet short-term filter needs so that discharge without a filter was preferred." The Angel catheter is the first medical device cleared by the FDA for PE prophylaxis in critically ill patients contraindicated to anticoagulation, added the company.
As summarized by Bio2 Medical, the trial was conducted in 20 ICUs across the United States with the treatment beginning at device insertion and ending 72 hours after the removal. Patients were evaluated daily for PE, lower extremity deep vein thrombosis (DVT), CRBSI, and major bleeding. The primary endpoint was freedom from clinically significant PE or fatal PE at the time of hospital discharge and 72 hours after removal of the Angel catheter. Secondary endpoints were acute proximal DVT, CRBSI, major bleeding events, and averted PEs.
All the devices were placed and retrieved without incident. None of the patients experienced clinically significant PE or fatal PE. Of the 129 patients who had a preremoval cavogram, 31 (24%) had thrombus within the filter, 14 (11%) of which were averted significant PEs. Twelve (86%) of the 14 patients underwent anticoagulation for an average of 4.1 days, five of whom also had a traditional IVC filter placed. In addition, there were no CRBSIs in more than 1,170 catheter days.
According to Bio2 Medical, through the pivotal study, the Angel catheter demonstrated its effectiveness in reducing PE. Furthermore, the Angel catheter generates financial savings to hospitals by reducing the costs associated with PE, complicated IVC filter removal, and interventional radiology suite time. The device has now clinically demonstrated its ability to avert PEs in high-risk patients by providing immediate PE prophylaxis, stated the company.
The Angel catheter is commercially available in the United States and the European Union.