European Regulators OK Frontline Medical’s Aortic Occlusion Device

Front Line Medical Technologies Inc. has nabbed CE Mark approval for its COBRA-OS (Control Of Bleeding, Resuscitation, Arterial Occlusion System) under the new European Medical Device Regulations (MDR).

“The CE marking of the COBRA-OS is momentous for our company, as it reinforces our commitment to better patient care,” Front Line Medical Technologies CEO Dr. Asha Parekh said. “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 4 French aortic occlusion device reportedly is the first of its kind to be approved through the new MDR system, according to the company. The product has been cleared by the U.S. Food and Drug Administration and approved by Canadian regulators. 
  
The COBRA-OS has an ultra-low profile and does not require an over-the-wire technique, which speeds up deployment and buys valuable time until definitive care can be provided. It is 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 putting the needs of patients first,” Front Line Medical Technologies Chief Medical Officer Dr. Adam Power stated. “CE marking of the COBRA-OS represents an advancement in the field, prioritizing 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,” Front Line Medical Technologies Product Director Seema Gogna added. “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.”
 
Front Line Medical Technologies Inc. is a Canadian medical device company developed the COBRA-OS, the smallest life-saving REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) device currently available. The COBRA-OS provides controlled occlusion of a patient’s aorta in critical medical situations when awaiting definitive care.