Front Line Medical Technologies today announced it received CE mark approval for its COBRA-OS device.
The CE mark gives EU medical providers access to the Control Of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS). The device already has FDA clearance and Health Canada approval.
“The CE marking of the COBRA-OS is momentous for our company, as it reinforces our dedication to technological excellence and our unwavering commitment to better patient care,” CEO Dr. Asha Parekh said in a news release. “Day in and day out, our pursuit of helping to save as many lives as we can is what drives our entire team, and this regulatory achievement means we are further on our way to accomplishing that goal.”
COBRA-OS is a 4 Fr aortic occlusion device that doesn’t require an over-the-wire technique. The company said it is one of the smallest life-saving Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) devices currently available with FDA clearance. It has a 4 Fr mini-access sheath kit and a 10 cc sword-handled syringe.
“The COBRA-OS – from conception to fruition is built on Front Line Medical Technologies’ commitment to always putting the needs of patients first,” CMO Dr. Adam Power said. “CE marking of the COBRA-OS represents a significant advancement in the field, prioritizing patient safety with a focus on reducing complications and simplifying aortic occlusion.”
More about the technology
COBRA-OS is made for physicians and potentially first responders to help patients survive non-compressional torso hemorrhage. About 90% of patients who suffer from internal bleeding outside of the hospital can’t make it to a hospital to get definitive care.
The device could bridge that time gap all allow patients to get that care. It is mostly used in REBOA procedures performed in hospitals on patients suffering trauma, postpartum hemorrhage and gastrointestinal hemorrhage.
Related: This device stops aorta blood flow to save lives
The device is inserted into the patient through the femoral artery in the groin. The physician uses a guidewire to push it up to the aorta and deploys the device to block blood flow from the aorta. Cutting the blood supply to the lower extremities temporarily limits circulation to the brain and the heart to prevent stroke or heart attack.
With the COBRA-OS inside the aorta, the physician pumps liquid into the device to create the occlusion. Once the aorta is blocked, the patient can receive definitive care. The device can be deflated and removed once the bleeding has subsided.
