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The Cardeon Cobra Catheter is indicated for use in open chest surgery on cardiopulmonary bypass up to 6 hours. It is used to provide separated perfusion of the arch and distal thoracic aorta with temperature differential, if desired.

The Cobra Catheter is an externally communicating device in limited contact with circulating blood.

The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.

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The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.

The Ascending Balloon Cannula is substantially equivalent to currently marketed devices used to directly cannulate and perfuse from a general cardiac surgery patients undergoing coronary artery bypass grafting or valve replacement and/or repairs on CPB via sternotomy. Aortic occlusion is achieved by the fluid inflation of an integrated balloon thereby preventing the backflow of blood into the surgical field. Additional lumens allow delivery of antegrade cardioplegia or venting of the aortic root. The subject and predicate devices use standard attachments for connection(s) to cardiopulmonary bypass circuit.

The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.

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The Cardeon® Aegis™ Catheter is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours.

Catheter, cannula and tubing, vascular, cardiopulmonary bypass