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Press Release

Bio2 Medical® Announces 510(k) Clearance from the FDA for the Angel® Catheter, the First Ever Prophylactic Use Indication for a Medical Device for Pulmonary Embolism

Bio2 Medical
Posted on: 25 Aug 16

GOLDEN, Colo., Aug. 24, 2016 /PRNewswire/ -- Bio2 Medical is pleased to announce the Angel® Catheter has received 510(k) clearance from the United States Food & Drug Administration (FDA). This 510(k) clearance 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 a novel alternative to IVC filters for PE protection in a vast patient population that has historically been underserved. The device 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 U.S. The entire team at Bio2 Medical is proud to provide physicians in the U.S. with a unique device that has the possibility of truly improving patient care and saving lives.

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 approval for clinical use by the FDA for this device will significantly impact trauma care. 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." 

Editor's Details

Mike Wood

Last updated on: 25/08/2016

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