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The pREBOA-PRO Catheter is intended for temporary partial or complete occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen.

The pREBOA-PRO™ Catheter is designed with flow channels to enable precise, smooth control of inflation and deflation of the balloon. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use.

The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a guidewire. In addition, the catheter is compatible with guidewires up to 0.025" that may be used to facilitate subsequent vascular procedures after a REBOA procedure. An orange peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. Below the balloon core aortic pressure monitoring is possible through the side arm of the sheath. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line safety valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The orange peel-away sheath can be separated from the catheter shaft after insertion if needed. The device is a single-use, sterile device.

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