The US FDA’s Breakthrough Devices Program is a programme for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The FDA states that the goal of the programme is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review.
Last week, Critical innovations — a US medical research and development company focused on creating products to help military personnel injured in combat — announced that they had received this Designation for its “Fast Onset Abdominal Management™ (F.O.A.M.™) device, which is designed to deliver a quickly-expanding foam to plug severe internal bleeding in trauma patients.
The rapidly expanding foaming agent is delivered into the body via a specialized needle and exerts pressure to stop intra-abdominal haemorrhage.
“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,” said Dr Ross Donaldson, President & CEO of Critical Innovations and an emergency physician at one of Los Angeles’ main trauma centres. “In such patients, the probability of death increases by approximately 1% for each 3-minute delay to surgery, meaning each minute counts.”
Dr Donaldson has been widely recognized for spearheading the development of emergency and trauma systems in Iraq and other countries in conflict, where he saw numerous such injuries.
Research and development for F.O.A.M is supported by funding from U.S. Army Medical Materiel Development Activity (USAMMDA), through the Medical Technology Enterprise Consortium (MTEC), under a contract worth over one million dollars.
This move reflects the US military’s mission to pursue treatments for uncontrolled blood loss. A large study published in 2012 that reviewed data on 10 years of military fatalities found that most battlefield casualties died of their injuries before ever reaching a surgeon and that 91 percent of potentially survivable deaths were due to heavy blood loss. Additionally, the majority of deadly military injuries occur in the abdominal region. This is fatal as compression [explain] in this area is not possible, meaning if someone with such an injury does not make it to a surgeon immediately they will most likely bleed-out.
Critical Innovations’ F.O.A.M.™ has the potential to save the lives of thousands of military men and women who suffer traumatic abdominal injuries on the field by bridging the gap between battlefield and surgeon and buying the patient some time to be treated in a proper surgical environment.
After the foaming agent is delivered via an auto-stopping needle, its main polymer solidifies at the internal body temperature. The foam then expands and exerts pressure.
When the injured person reaches a surgeon, they can reverse the process with cooled liquid to wash it away. If no further procedure is required, the foaming agent is designed to gradually dissolve in the body.
“The product is an easily transportable medical device that can be used by non-surgeon providers within the battle area, before or during medical evacuation. F.O.A.M.™ is field-adapted for long shelf life, resorbable by the body with minimal risk for complications, and easily removable if needed for subsequent surgery,” says Critical Innovations.
To date, the company has developed a proof-of-concept device and performed initial animal testing.