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Abstract

An intra-aortic balloon assembly which includes an hemostasis device slidably mounted to a balloon catheter, and method for percutaneous insertion of such assembly. The hemostasis device provides a distal constant diameter segment dimensioned to minimize initial resistance to the insertion of the hemostasis device, integrated with a second proximal segment of larger constant diameter via a transition segment. The second constant diameter segment is proportioned to fill the opening in the patient's skin created by the insertion of the intra-aortic balloon and thereby stop any bleeding from the femoral artery at the insertion site. The method includes the steps of (1) percutaneously inserting the intra-aortic balloon into the femoral common artery, with or without the use of a tear-away insertion sheath, (2) removing the insertion sheath (if one is used) after insertion of the intra-aortic balloon assembly, and (3) inserting the hemostasis device into the patient's skin at the insertion site to stop bleeding which may occur upon sheathless insertion of the wrapped balloon or removal of the insertion sheath.

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First Claim