This achievement marks a significant milestone in the company’s journey, granting European Union medical providers access to a life-saving device and highlighting the company’s global expansion efforts.
The CE marking was granted under stringent European Medical Device Regulations, signifies the approval of the COBRA-OS as a safe and effective medical device for aortic occlusion. Notably, the COBRA-OS is the first-of-its-kind 4 French aortic occlusion device to secure approval through the new MDR system, which the company says further solidifies its position as an industry leader.
Dr. Asha Parekh, CEO of Front Line 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.”
The device distinguishes itself with its ultra-low-profile design, eliminating the need for an over-the-wire technique and expediting deployment. The company says this streamlined approach not only saves crucial time but also enhances patient outcomes by facilitating swift access to definitive care.
Dr Adam Power, CMO of Front Line emphasized the device’s patient-centric design, he said: “CE marking of the COBRA-OS represents a significant advancement in the field, prioritizing patient safety with a focus on reducing complications and simplifying aortic occlusion.”
Furthermore, the device is accompanied by a 4 French mini-access sheath kit and a 10-cc sword-handled syringe, offering convenience and versatility to medical practitioners.
Seema Gogna, director of products at the company highlighted the company’s commitment to global accessibility. She 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 device’s compact size and innovative design allow for minimally invasive procedures with enhanced precision and safety, revolutionizing the approach to aortic occlusion surgeries.
Its streamlined construction ensures ease of deployment and optimal positioning within the aorta and is designed to optimize performance and mitigate the risk of complications. Its advanced monitoring capabilities enable real-time assessment of blood flow and pressure, empowering surgeons to tailor occlusion levels to individual patient needs.
The COBRA-OS also offers the capability of Partial REBOA which involves adjusting the balloon to permit some distal blood flow to the lower limbs, particularly beneficial when patients face extended transit times to reach definitive care.
