Importance

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Abstract

A method and endovascular system, such as a balloon catheter, for detecting the absence of neointimal coverage of bare or drug-eluting metal stents, featuring two (bipolar systems) or more electrodes (multipolar systems). The distal part of the device has an expandable platform, such as an inflatable balloon, for providing transient mechanical contact of the electrodes to the stented vessel segment. The electrodes on the expandable platform have a circumferential-symmetric array, i.e., arrangement in identical circular sectors. For example, the electrodes are arranged in semicircles, i.e., at 90 and 180 degrees, when using a bipolar catheter system, or they are arranged in quarter-sections, i.e., at 90, 180, 270, and 360 degrees, when using a quadrupolar catheter system. The electrodes of the endovascular device connect with a direct current (DC) or alternating current (AC) measurement unit. With multipolar systems, rotational impedance measurement technology is used for accurate detection of exposed (non-covered) stent struts and is defined herein as sequential (clock-wise or counterclock-wise) testing of each single electrode against the remaining electrically interconnected electrodes. The described endovascular system requires direct mechanical contact of at least 2 electrically non-interconnected electrodes with the stent to induce short-circuit current. The method and system can distinguish complete neointimal stent coverage, defined as consistently high impedance values in all measurements, from partial neointimal coverage, defined as a mix of high and low impedance values, from missing neointimal coverage, defined as consistently low impedance values in all measurements.

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First Claim