FDA clears catheter to prevent blood clots during hospital stays

The FDA cleared BiO2 Medical’s catheter for the protection of critically ill patients from pulmonary embolism. It is the first venous catheter to be approved for prophylactic use in addition to traditional filter and catheter indications.

Hospitalized patients’ risk for pulmonary embolism is greatest within the first 10 days after admission, and the majority of PEs occur within the first 21 days in intensive care, according to BiO2. Pulmonary embolism is a condition where one or more of the arteries in the lungs is blocked by a blood clot, which most commonly originate in the legs.

The Angel Catheter is a triple-lumen catheter that comprises a temporary inferior vena cava filter attached to a central venous catheter and it reduces PE rates by trapping pulmonary emboli, according to a statement. It is designed to prevent PE in patients for whom anticoagulation therapy poses a high risk of complications.

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The catheter does not require fluoroscopic guidance during deployment and is designed for bedside placement in high-risk patients, BiO2 Medical said in the statement. It  can be safely retrieved once no longer needed, and is an alternative to inferior vena cava (IVC) filters, which are small, cone-shaped devices implanted to catch emboli before they travel to the heart and lungs.

“The majority of pulmonary emboli occur in the first three to four days after injury. Being able to protect our patients from pulmonary embolism during this time period, which is also the time period where traditional chemoprophylaxis is frequently contraindicated, will be extremely beneficial,” said Dr. John Myers, a professor and chief of the Division of Trauma and Emergency Surgery at the University of Texas Health Science Center, in the statement. The retrievable nature of the Angel catheter also eliminates some long-term complications that accompany current IVC filters, such as device migration or fracture, erosion and caval thrombosis, or local blood clotting in the vena cava, Myers said.

Most recently, the Golden, CO-based BiO2 bagged about $9 million in a Series D round and raised an additional $5 million in debt financing in January this year. It previously pulled in a $12 million Series C in September 2012 to commercialize the catheter, and a $13.7 million Series B just 6 months prior. The device was CE-marked in December 2012.

- here's the statement

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