BiO2 Medical has announced the enrolling of first three subjects in the new US Food and Drug Administration (FDA) early feasibility pilot study for the Angel catheter.
Research teams led by Dr John Holcomb at University of Texas, Houston (Memorial Hermann Hospital) and Dr Larry Martin at University of Mississippi, Jackson participated in these cases with the first subject enrolled at UT Houston.
The Angel catheter is an innovative approach to pulmonary embolism (PE) prevention. The device combines the technology of a retrievable, nitinol inferior vena cava (IVC) Filter permanently attached to a multi-lumen central venous catheter (CVC), simultaneously providing prophylactic PE protection and central venous access for critically ill patients.
The novel design of the Angel catheter significantly reduces the known complications of IVC filters by ensuring 100% removal of the IVC filter when the CVC is retrieved.
The device allows the critical care physician to place an IVC filter at the patient’s bedside without the need for imaging at the time of placement. The Angel catheter is intended for the prevention of clinically significant pulmonary embolism (PE) in patients at high risk for PE or recurrent PE and recognized contraindications to standard pharmacological thromboprophylaxis therapy.
BiO2 Medical clinical affairs vice president Margaret Tumas noted that this early feasibility study clinical trial will be completed in early 2014.
The ensuing pivotal trial is being planned to support the clinical use of the Angel catheter in the prevention of pulmonary embolism and in particular to include the prophylactic use of a vena cava filter in high risk patients with or without a proven history of PE or deep vein thrombosis, the first of its kind.