Fort Detrick, Maryland – The US Army Medical Materiel Agency (USAMMA) is supporting a pivotal clinical trial to test the safety and effectiveness of a self-expanding polyurethane foam device to stop massive intracavitary abdominal bleeding.
The programme to develop the foam started in 2010, in collaboration between DARPA, Massachusetts General Hospital, Harvard Medical School and a private vendor. The idea is that the foam will rapidly compress major abdominal bleeding caused by trauma, and prevent death by exsanguination.
The device itself resembles a caulking gun, and contains an expandable foam for injection into a patient by a trauma surgeon. The two components that form the foam are mixed within the injector, and the foam rapidly expands in the abdomen to about 35 times its original volume, surrounding the internal organs. It can be left within the patient for up to three hours.
“Right now, we are looking at this device as a potential stop-gap for patients awaiting surgical care,” said Leigh Anne Alexander, USAMMA product manager. “This is not going to repair the injury, but it could be a bridge to surgery, keeping the patient alive long enough to give them a fighting chance at survival.”
The army took over the project in 2015 following promising results in animal studies. Clinical trial site selection is now under way, and it is hoped that the trial itself will start in 2018.