Canada-based Front Line Medical Technologies has secured CE marking for its Control Of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS).

COBRA-OS is a four-French aortic occlusion device. It is designed to provide controlled occlusion of a patient’s aorta in critical medical scenarios while awaiting definitive care.

The system is said to be a cost-effective, easy-to-use device for temporary haemorrhage control and resuscitation.

It has already received the US Food and Drug Administration (FDA) clearance and approval from Health Canada in 2021.

Medical practitioners in the European Union (EU) will now have full access to this occlusion device, approved through the new European Medical Device Regulations (MDR) system.

Front Line Medical Technologies CEO Asha Parekh said: “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.

“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 said to have an ultra-low profile. It has a convenient four-French mini-access sheath kit and a 10-cc sword-handled syringe.

Additionally, it eliminates the need for an over-the-wire technique, facilitating rapid deployment and buying crucial time until definitive care is available.

The device can offer complete occlusion, intermittent occlusion, or partial occlusion as required by the patient. Furthermore, it features a Safety Shoulder Reservoir designed to mitigate the risk of aortic rupture during inflation.

Front Line Medical Technologies products director Seema Gogna said: “With the achievement of CE marking, we are moving the needle in expanding access on a global scale, and we will continue to take steps towards touching more lives and improving outcomes.”

The Canadian medical device company also has the life-saving Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) device. It is already approved in the US, EU, and Canada.