European Registry Data Published for BiO2 Medical's Angel Catheter

October 8, 2015—BiO2 Medical Inc. announced the publication of key clinical data on the use of the company’s Angel catheter in Europe. The company also advised on the ongoing enrollment in the United States’ pivotal study of the device.

The Angel catheter, which is intended to provide pulmonary embolism protection, can be placed directly at the bedside without the need for fluoroscopy, and can be retrieved when no longer required. The Angel catheter has received European CE Mark approval and is commercially available in countries that recognize the CE Mark. The Angel catheter is limited to investigational use only in the United States, advised the company.

Findings from the European registry were published by Fabio S. Taccone, MD, et al in the Journal of Trauma and Acute Care Surgery (2015;79:456–462). The investigators reported the results of the first 60 patients in Europe that received placement of the Angel catheter and concluded that early bedside placement of the device is possible. The findings suggest that this is a safe, effective alternative to short-term pulmonary embolism prophylaxis for high-risk patients with contraindications to anticoagulation.

In the company’s press release, Dr. Taccone commented, “Critically ill patients are at risk of several life-threatening complications. Many studies have found that acute pulmonary embolism was an undiagnosed cause of death in postmortem analyses. Unfortunately, most of these patients also have a high risk for bleeding and use of medications, as thromboprophylaxis in this group remains limited. The use of a central venous catheter/inferior vena catheter filter, such as the Angel catheter, may open a new approach to preventing pulmonary embolism as it can be inserted directly at the bedside by intensivists; it has none of the potential adverse events associated with implanted inferior vena catheter filters; and it can be easily removed when the risk of bleeding is over and anticoagulants can be administered.”

The pivotal investigation to support US Food and Drug Administration approval of the Angel catheter continues with enrollment well ahead of expectations. As of October 8, 2015, the study has enrolled 83% of the targeted evaluable patients, which is faster than expected and speaks to promising physician acceptance of the device, according to the company.

In February 2015, BiO2 Medical announced the beginning of enrollment in the prospective, single-arm Angel catheter clinical trial. At the successful completion of the study, the company will seek a prophylactic indication for the device.