BiO2 Medical, Inc. a Texas based medical device manufacturer with corporate offices in San Antonio, Texas, and R&D and manufacturing operations in Golden, Colorado, announced today that it has received CE Mark approval for the Angel™ Catheter, a Nitinol Inferior Vena Cava (IVC) filter, permanently attached to a central venous catheter (CVC) for the use of preventing Pulmonary Embolism (PE) in critically ill patients. This novel IVC filter/CVC combination device is the first IVC filter with a prophylactic use indication, and allows attending physicians the ability to place an IVC filter bedside in the Intensive Care Unit (ICU), in a procedure resembling a routine CVC placement procedure.
According to Luis F. Angel, MD, BiO2 Medical's Chief Medical Officer and inventor of the Angel™ Catheter, "Obtaining the CE clearance for commercialization of the Angel™ Catheter in Europe is a significant step in our goal to provide an alternative for critically ill patients at high risk of Pulmonary Embolism (PE). It also validates a long and complex process of extensive testing for the use of our device as a prophylaxis against PE."
"With CE Mark approval for the Angel™ Catheter, and preliminary safety data from a First in Man clinical study, these are exciting times for the entire team at BiO2 Medical. We've been working diligently over the past several years to bring this product to market, and I am justifiably impressed and proud of everyone who has helped to bring this life saving device to market," stated Christopher E. Banas, BiO2 Medical's Chairman and Chief Executive Officer.