Bio2 Medical touted data yesterday from the pivotal study of its Angel catheter in 163 critically ill patients with high risk of acute pulmonary embolism and contraindications to anticoagulation.
The study met its safety endpoints and demonstrated a significant reduction in clinically significant and fatal pulmonary embolism, according to the company.
The trial evaluated patients daily for pulmonary embolism, lower extremity deep vein thrombosis, catheter-related blood stream infections and major bleeding. The primary endpoint was freedom from clinically significant PE or fatal PE at the time of discharge and 72 hours after the Angel catheter was removed.
Secondary endpoints included acute proximal DVT and averted PEs.
All of the devices were placed and removed without incident, Bio2 reported. None of the enrolled patients suffered clinically significant PE or fatal PE.
Among the 129 patients who had a pre-removal cavogram, 31 had thrombus within the filter, 11% of which were averted significant PEs.
There were no catheter-related blood stream infections in over 1,170 catheter days, according to Bio2.
“Acute PE kills more than 100,000 Americans every year, and many more around the world. This study of a combined IVC filter/central venous catheter was the culmination of a panel of dedicated investigators with careful guidance by the FDA,” primary investigator Dr. Victor Tapson said in prepared remarks. “The efficacy and safety of the device, simple bedside placement, and the need to remove it before discharge make it very appealing. Nearly the entire cohort had crucial, yet short-term filter needs so that discharge without a filter was preferred.”
The device is the 1st to be cleared by the FDA for PE prophylaxis in critically ill patients contraindicated to anticoagulation.
“The publication of the results of the Angel Catheter pivotal study represents an opportunity to create awareness and further the goal of making this unique, lifesaving product available to the American public,” CEO Christopher Banas added. “Working collaboratively with the FDA as an initial participant in the FDA’s new Early Feasibility Study Program enabled Bio2 Medical to develop a clinical protocol which contributed to the pivotal study being completed 9 months ahead of schedule due to its fast enrollment. Congratulations to the primary investigators, whose support was a major factor in the study’s success.”