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.