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Product approval

Bio2 Medical gains FDA approval for Angel Catheter

Angel Catheter
Angel Catheter is the first ever prophylactic use indication for a medical device for PE

Bio2 Medical has received 510(k) clearance from the FDA for it’s Angel Catheter that includes a first ever, prophylactic indication for a medical device to protect critically ill patients at high-risk for pulmonary embolism (PE) and contraindicated for anticoagulation. The Angel Catheter provides an alternative to IVC filters for PE protection in a vast patient population that has historically been underserved.

The Angel Catheter is designed for bedside placement, without the need for fluoroscopic guidance, and is designed to be safely retrieved in all cases once no longer indicated. The Angel Catheter features a temporary Inferior Vena Cava (IVC) filter that is permanently attached to a Central Venous Catheter (CVC), and has been designed to reduce the rates of PE-related morbidity and mortality by trapping clinically significant pulmonary emboli. The Angel Catheter is now commercially available in the US.

John Myers

“The approval for clinical use by the FDA for this device will significantly impact trauma care,” said Dr John G Myers, Professor and Chief of the Division of Trauma and Emergency Surgery at the University of Texas Health Science Center in San Antonio, had this response to the news. “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. In addition, this device also obviates the significant long-term complications of the currently available indwelling vena cava filters which include migration, fracture, erosion and caval thrombosis, where the current removal rate is dismal.”

Luis Angel

"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,” said Dr Luis F Angel, the inventor of the Angel Catheter and Chief Medical Officer at Bio2 Medical. “It also provided us the possibility to evaluate this device in the US in a research environment that is proven to be the most effective and scientifically sound. In the end, this process was very beneficial to introducing a new device with a new indication and also for the FDA in learning about future products early in their life cycle."

The Angel Catheter is indicated for up to 30 days use, and it is intended to be used during this critical time period, in which anticoagulation therapy poses a high risk of complications, including major bleeding and death, and in which patients are at the highest risk of developing a life threatening PE.

“We are excited to enter into this new commercial phase and to have the opportunity to fulfil our company's mission to improve patient outcomes by offering our life-saving product to the American public,” said Christopher E Banas, Chairman and Chief Executive Officer of Bio2 Medical. “The transition to a successful and profitable company is fully underway with the hiring and training of a national direct sales team, led by Jeffrey Hutchison, our new Vice President of US Sales."