Front Line Medical today announced that its COBRA-OS (Control Of Bleeding, Resuscitation, Arterial Occlusion System) has officially been granted CE marking under the new European Medical Device Regulations.
EU medical providers now have full access to this 4 French aortic occlusion device, the first to be approved through the new MDR system. Already with FDA clearance and Health Canada approval, the COBRA-OS CE marking highlights the company’s substantial market expansion.
“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,” said Dr. Asha Parekh, CEO of Front Line Medical Technologies. “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.”
The COBRA-OS features an ultra-low profile and doesn’t require an over-the-wire technique, which speeds up deployment and buys valuable time until definitive care can be provided and is conveniently accompanied by a 4 French mini-access sheath kit and a 10 cc sword-handled syringe.
