BiO2 Medical Completes Pivotal Angel Catheter Clinical Trial

December 18, 2015—BiO2 Medical announced that the Angel Catheter Clinical Trial, the pivotal investigation of the company’s Angel catheter in the United States, has successfully achieved its target of 150 evaluable patients. The pivotal study has exceeded original forecasts and concluded 1 year earlier than anticipated, noted the company.

BiO2 Medical anticipates a 90-day period for US Food and Drug Administration 510(k) clearance, to be followed by commercialization of the Angel catheter between Q2 and Q3 2016.

An interview with the inventor of the Angel catheter, Luis F. Angel, MD, was published in the October 2015 issue of Endovascular Today (2015;14:138). Dr. Angel discussed insights learned from participation in the FDA’s early feasibility pilot program and his initiatives for the prevention of pulmonary embolism. In addition to serving as Chief Medical Officer for BiO2 Medical, Dr. Angel is Director of interventional pulmonary, pulmonary and critical care medicine, University of Texas Health Science Center at San Antonio in San Antonio, Texas.

According to the company, the Angel catheter features the rapid and acute protection of a retrievable nitinol inferior vena cava (IVC) filter permanently attached to a multilumen central venous catheter (CVC), which simultaneously provides pulmonary embolism (PE) protection and central venous access for patients at high risk of PE. The Angel catheter can be placed directly at the bedside, without the need for fluoroscopy, and ensures retrieval when it is no longer indicated.

The device has received European CE Mark approval and is commercially available in countries recognizing the CE Mark. In the United States, the Angel catheter is classified as an investigational device, limited by law to investigational use.

In October, the company announced that findings from the European Angel Catheter Registry were published by Fabio Silvio Taccone, MD, et al in the Journal of Trauma and Acute Care Surgery (2015;79:456–462). Reporting results on the first 60 patients in Europe that received placement of the Angel catheter, the investigators concluded, “Early bedside placement of an IVC filter-catheter is possible, and our results suggest that this is a safe, effective alternative to short-term PE prophylaxis for high-risk patients with contraindications to anticoagulation”

Dr. Taccone commented in BiO2 Medical’s press release in October, “Critically ill patients are at risk of several life-threatening complications. Many studies have found that acute PE 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 CVC/IVC filter, such as the Angel catheter, may open a new approach to preventing PE as it can be inserted directly at the bedside by the intensivists, it has none of the potential adverse events associated with implanted IVC filters, and it can be easily removed when the risk of bleeding is over and anticoagulants can be administered.”