The U.S. Food and Drug Administration (FDA) recently announced that it has granted 510(k) clearance for the Angel Catheter, the first-ever prophylactic indication for pulmonary embolism.
The clearance, granted to Bio2 Medical, applies to the world’s first prophylactic indication that approves a medical device designed to protect patients who are critically ill and who are at high risk for their pulmonary embolism (PE) as well as contraindicated for anticoagulation.
"The approval for clinical use by the FDA for this device will significantly impact trauma care,” Dr. John Myers, chief of the Division of Trauma and Emergency Surgery at the University of Texas Health Science Center, said. “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 cava thrombosis, where the current removal rate is dismal."
This is a significant step forward for both the health industry and patients.
"This is an important advance in the care of high-risk patients that allows for bedside initiation of mechanical protection from pulmonary embolism with a truly temporary device that also provides vascular access,” Dr. John Kaufman, director of Dotter Interventional Institute, said.
