Front Line Medical Technologies has announced that the US Food and Drug Administration (FDA) has cleared its COBRA-OS (Control of bleeding, resuscitation, arterial occlusion system). The COBRA-OS is the first 4 French resuscitative endovascular balloon occlusion of the aorta (REBOA) device and, according to a press release, is the smallest on the market.
The COBRA-OS is capable of providing 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.
“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 Adam Power, practicing vascular surgeon at London Health Sciences Centre (London, Canada) and cofounder 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 five to 10 minutes or longer; the COBRA-OS has taken just over a minute in studies. Because of its smaller size, healthcare 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 Asha Parekh, cofounder 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 haemorrhage in trauma, postpartum haemorrhage, and gastrointestinal haemorrhage. While it has been primarily performed in hospital, it is currently also being deployed in prehospital settings and military environments and being investigated for nontraumatic cardiac arrest.
