A plastic tube with a length of 142 cm with a plastic balloon at one end (so-called ‘balloon catheter’). The proximal segment of the catheter has a diameter of 0,63 mm and is made of hypotube material and coated with polytetrafluorethylene (PTFE). The distal segment of the catheter has a diameter in a range from 0,79 to 1,02 mm and is made of polyether bloc amide (PEBA) material and coated with hydrophilic material. The balloon has a length of 6 to 27 mm and a diameter of 2 to 5 mm. The tube has a Luer connection, an atraumatic (flexible) tip and 2 golden marker bands. The Luer connection makes it possible to connect the tube to an inflating device which is used to inflate the balloon. The atraumatic tip is used to move the catheter via a vein up through the body into the coronary artery. When the catheter is on the right place in the coronary artery, the balloon is inflated so that the fatty deposits (atherosclerotic plaque) are pressed against the wall of the vein. By compressing the plaque, the inside diameter of the vein increases. The marker bands make it possible to locate the exact position of the atraumatic tip in the body. The balloon catheter is removed from the body and discarded after treatment. The article is presented in packaging and is sterilised.
[1][1]. https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32014R1038