Front Line Medical Technologies has 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.
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EU medical providers now have full access to this unique 4 French aortic occlusion device, the first of its kind 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, solidifying Front Line Medical Technologies as a true industry player.
“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 is most notable for its ultra-low profile. It also 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.
“The COBRA-OS – from conception to fruition is built on Front Line Medical Technologies’ commitment to always putting the needs of patients first,” said Dr. Adam Power, CMO of Front Line Medical Technologies. “CE marking of the COBRA-OS represents a significant advancement in the field, prioritising patient safety with a focus on reducing complications and simplifying aortic occlusion.”
“Entrance into the EU market as an avenue to increase medical access to COBRA-OS is a natural move for the company, considering our mission of reaching more patients,” said Seema Gogna, director of products of Front Line Medical Technologies. “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.”
