Smallest life-saving bleeding control device gets FDA clearance

FDA has cleared Front Line Medical Technologies' COBRA-OS (control of bleeding, resuscitation, arterial occlusion system). The COBRA-OS is the first 4 French REBOA (resuscitative endovascular balloon occlusion of the aorta) device and it is the smallest on the market. It is a cost-effective, innovative, easy-to-use aortic occlusion device with an extremely low profile for temporary hemorrhage control and resuscitation. 

The COBRA-OS can provide full occlusion, intermittent occlusion, or partial occlusion depending on the patient’s need, and also has a unique Safety Shoulder Reservoir   incorporated into the device to help prevent aortic rupture during inflation. The medical device allows frontline personnel to save more lives by controlling patients’ bleeding in fewer steps and less invasively, potentially decreasing complications.

REBOA is a minimally invasive procedure used in emergency situations, that deploys an endovascular occlusion balloon in the aorta to temporarily stem blood flow below the device and increase blood flow above it to the brain and heart.

“With the extremely low profile of the COBRA-OS, we can hopefully help to reduce REBOA procedure times and access site complications. With the time saved and fewer complications, we have the potential to increase the benefits of REBOA for trauma patients and beyond,” said Dr Adam Power, practicing vascular surgeon and co-founder of Front Line Medical Technologies. “Our goal is to increase access to life-saving REBOA procedures and ultimately decrease the rates of preventable deaths due to blood loss.”

Typical REBOA procedures can take between 5 to 10 minutes or longer; the COBRA-OS has taken just over a minute in studies. Because of its significantly smaller size, health care personnel can quickly and easily deploy the COBRA-OS, reducing the time of the procedure and potentially improving patient outcomes.

“REBOA is still an evolving procedure, and the COBRA-OS is the latest device to push the limit further in terms of practicality, especially for out-of-hospital cases,” said Dr Asha Parekh, co-founder and CEO of Front Line Medical Technologies. “The COBRA-OS provides medical professionals with a simple and effective device, which can expand REBOA use and help more patients survive traumatic injuries. FDA clearance is a major milestone and with North America now covered, we will continue to grow and expand into other countries.”

The medical device can be used in multiple situations, including non-compressible torso hemorrhage in trauma, postpartum hemorrhage and gastrointestinal hemorrhage. While it has been primarily performed in-hospital, it is currently also being deployed in pre-hospital settings and military environments and being investigated for nontraumatic cardiac arrest.

The COBRA-OS recently received Health Canada approval as well.