Enrollment Begins for Pivotal Trial of BiO2 Medical's Angel Catheter and IVC Filter

February 19, 2015—BiO₂ announced that the first three patients have been enrolled for the Angel catheter clinical trial, a prospective, single-arm clinical investigation of the device. Site initiation visits are underway with a goal to include up to 30 sites in the United States. At the successful completion of the study, BiO₂ Medical will be seeking a prophylactic indication, the first for an inferior vena cava (IVC) filter, the company stated.

The Angel catheter features a retrievable nitinol IVC filter permanently attached to a multilumen central venous catheter, intended to provide central venous access while protecting against pulmonary embolism (PE) in patients who are at high risk for it. The device allows for placement at the patient’s bedside without the need for fluoroscopy and ensures complete removal of the IVC filter when the catheter is retrieved.

“Acute pulmonary embolism continues to be a vexing problem, particularly in high risk, ICU patients. Frequently, anticoagulant prophylaxis is contraindicated. IVC filters clearly prevent PE in the vast majority of cases,” stated Victor Tapson, MD, who is lead principal investigator for the Angel catheter clinical trial. “The Angel catheter is an easily placed and easily retrieved IVC filter built into a multilumen central venous catheter. It is intended for use in critically ill patients, essentially all of whom are at risk of acute VTE [venous thromboembolism] and thus, fatal PE. We are very excited about this study.”