BiO2 Medical has obtained CE mark approval for its Angel Catheter, a Nitinol inferior vena cava (IVC) filter, with a prophylactic use indication.
The IVC filter is permanently attached to a multi-lumen central venous catheter (CVC) to prevent pulmonary embolism (PE) in critically ill patients.
The IVC filter/CVC combination device facilitates attending physicians the ability to place an IVC filter bedside in the intensive care unit (ICU).
BiO2 Medical chief medical officer Luis Angel said receiving CE mark is a significant step in the company’s goal to provide an alternative for critically ill patients at high risk of PE.
"It also validates a long and complex process of extensive testing for the use of our device as a prophylaxis against PE," Angel added.