Critical Innovations received breakthrough device designation from the FDA for its Fast Onset Abdominal Management (FOAM) device.
The device is designed to deliver quick-expanding foam to tamponade severe internal bleeding in trauma patients, according to the Inglewood, Calif.-based company. It controls severe bleeding in the abdomen when surgical intervention is not immediately available.
FOAM is delivered to the boat through a specialized auto-stopping needle where the foaming agent can then expand and exert pressure to stop bleeding. Its polymer component becomes solid at warmer temperatures, allowing surgeons to reverse the process by washing with a cooler liquid if needed. If no further procedure is needed, the foaming agent can gradually dissolve for removal.
“The goal of the FOAM device is to provide a lifesaving bridge to surgical care for patients who might otherwise die from their injuries,” president & CEO Dr. Ross Donaldson said in a press release. “In such patients, the probability of death increases by approximately 1% for each 3-minute delay to surgery, meaning each minute counts.”
R&D for the FOAM device was supported by funding from U.S. Army Medical Material Development Activity and through the Medical Technology Enterprise Consortium in a contract for more than $1 million.
“Military funding of FOAM device development has been key to our success so far,” Donaldson said. “We look forward to engaging with the FDA through the Breakthrough Devices Program.”