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June 29, 2021
Front Line Medical’s Cobra-OS Device Cleared by FDA
June 29, 2021—Front Line Medical Technologies, Inc. announced that the FDA has cleared the company’s Control of Bleeding, Resuscitation, Arterial Occlusion System (Cobra-OS). The Cobra-OS is a 4-F device for resuscitative endovascular balloon occlusion of the aorta (REBOA). In February 2021, the company announced that the device received Health Canada approval.
According to the company, the Cobra-OS can provide full occlusion, intermittent occlusion, or partial occlusion as needed. The device’s safety shoulder reservoir is intended to help prevent aortic rupture during inflation. Because of its small size, the Cobra-OS can be quickly and easily deployed, reducing the time of the procedure and risk of complications and potentially improving patient outcomes.
The Cobra-OS can be used in multiple situations, including noncompressible torso hemorrhage in trauma, postpartum hemorrhage, and gastrointestinal hemorrhage. Although REBOA has been primarily performed in-hospital, it is currently also being deployed in prehospital settings and military environments and being investigated for nontraumatic cardiac arrest, noted the company.
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