The MICHELER Heart Vent Catheter (MHVC) is FDA cleared K200289. The MHVC is a soft balloon-tipped catheter. It is inserted through the open left atrium during mitral valve surgery or through the right superior pulmonary vein on the beating heart and across the mitral valve into the left ventricle. Uniquely, the device is securely positioned and maintained in the LV by inflating a soft positioning balloon against the mitral annulus/valve. The balloon inflates, keeping the catheter tip below the mitral valve to ensure drainage of air, blood and debris from the left atrium and left ventricle. The MHVC consists of a flexible tube with a soft compliant balloon located on the distal portion of the tube with drainage holes both proximal and distal to the balloon. The catheter is provided with a tapered tip, a malleable stylet and depth markings to insure smooth insertion. Overall length is approximately 43.8 cm (17.25 in). The inflatable balloon is filled with sterile saline solution and holds the catheter in place at the desired location. Catheter 16 fr. O.D. (5.5 mm dia.) Supplied sterile, for one time use.
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