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Bio2 Medical gets FDA 510(k) clearance for pulmonary embolism protection device

Bio2 Medical has secured 510(k) clearance from the US Food & Drug Administration (FD) for its Angel Catheter to protect critically ill patients from acute Pulmonary Embolism (PE).

The approval was granted for prophylactic indication to protect critically ill patients at high-risk for PE and contraindicated for anticoagulation.

Designed for bedside placement without the need for fluoroscopic guidance, the Angel Catheter is an alternative to inferior vena cava (IVC) filters for PE protection in a range of patient population.

The catheter features a temporary IVC filter, which is permanently attached to a central venous catheter (CVC).

It will also reduce the rates of PE-related morbidity and mortality by trapping clinically significant pulmonary emboli.

According to the company, the Angel Catheter is currently commercially available in the US.

Bio2 Medical, chief medical officer and Angel Catheter inventor Dr Luis Angel said: "The Early Feasibility Pilot Program was a great opportunity to formally introduce this device to the FDA and to understand their requirements and our vision for this product.

“It also provided us the possibility to evaluate this device in the United States in a research environment that is proven to be the most effective and scientifically sound.”

Bio2 Medical Chairman and CEO Christopher Banas said: "We are excited to enter into this new commercial phase and to have the opportunity to fulfill our company's mission to improve patient outcomes by offering our life-saving product to the American public.”


Image: Bio2 Medical’s Angel Catheter. Photo: courtesy of PRNewsFoto/Bio2 Medical, Inc.