Critical Innovations has received FDA breakthrough device designation for its “fast onset abdominal management” (F.O.A.M) device, which is designed to deliver a quickly-expanding foam to tamponade severe internal bleeding in trauma patients. The US Army Medical Materiel Development Activity (USAMMDA), through the Medical Technology Enterprise Consortium (MTEC), under a contract worth over one million dollars, supports the research and development of F.O.A.M.
According to a press release, F.O.A.M is designed to control severe intra-abdominal bleeding in critically ill trauma patients, when surgical intervention is not immediately available. Once delivered into the body via a specialised auto-stopping needle, its foaming agent expands and exerts pressure. Its main polymer component is unusual in that it exhibits reverse-phase-shift properties, meaning it becomes more solid at warmer temperatures (e.g. body temperature). If a subsequent surgical procedure is required, a surgeon can reverse the process and wash it away with cooled liquid. However, if no further procedure is required, the foaming agent should gradually dissolve to be removed by the body.
Ross Donaldson (Department of Emergency Medicine, David Geffen School of Medicine, UCLA, Los Angeles, USA), president & CEO of Critical Innovations, comments: “The goal of the F.O.A.M device is to provide a lifesaving bridge to surgical care for patients who might otherwise die from their injuries. In such patients, the probability of death increases approximately 1% for each three-minute delay to surgery, meaning each minute counts.” He adds: “Military funding of the F.O.A.M. device development has been key to our success so far.”
To date, the company has developed a proof-of-concept device and performed initial animal testing. The breakthrough device programme aims to help speed up the development process through expedited regulatory assessment and review of medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.