BiO2 Medical IVC Filter Catheter Receives CE Mark

BiO2 Medical, a six year old San Antonio, Texas-based medical device manufacturer, has received CE marking for its triple lumen Angel catheter. The catheter is an interior vena cava (IVC) filter made of nitinol, and is permanently attached to a central venous catheter in order to prevent pulmonary embolism (PE) in critically ill patients. The device can reportedly be placed beside a patient’s bed without the need for fluoroscopy. According to the company, it is the first IVC filter to receive the CE mark approval for prophylactic (preventative) indications.

PE is a blockage of the main artery of the lung or one of its branches by a substance that has travelled from elsewhere in the body through the bloodstream—an embolism. The condition most commonly results from deep vein thrombosis (a blood clot in the deep veins of the legs or pelvis) that migrates to the lung, a process termed venous thromboembolism.

“This represents an important milestone for BiO2 Medical and the commercialization of the Angel Catheter,” said Christopher E. Banas, BiO2 Medical’s Chairman and CEO. “We are pleased to provide physicians with a technology that offers immediate Pulmonary Embolism protection for ICU [intensive care unit] patients during the critical unprotected window, while simultaneously allowing for lifesaving fluid and medication administration.”

The device was introduced at the recent U.K. Intensive Care Society’s “State of the Art” Meeting in London, England, that was held between Dec. 11 and 12. A call to the company about which countries the Angel catheter initially would be marketed to was not immediately returned.

Photo of Angel Catheter courtesy of BiO2 Medical.