Cutting balloon: A novel approach to percutaneous angioplasty

Balloon angioplasty typically injures the vessel wall by inducing irregular intimai tears, splits and stretches.1 Proliferative response to this injury,2 and elastic recoil3 after balloon angioplasty are implicated as causes of restenosis and acute closure, respectively. We hypothesized that sharp and regular endovascular surgical incisions may enhance the success of angioplasty by limiting both injury and elastic recoil. We designed devices to make radially directed, longitudinal surgical cuts from the luminal surface deepening into the medial layer. In this study we used 1 of the possible designs (Figure 1). One to 4 cutting edges of 0.1 to 0.4 mm metal blades were mounted on the surface of balloon catheters parallel with the longitudinal axis of the balloon (cutting balloon). The aims of the study were to (1) determine the immediate morphology of incisions made with the cutting balloon; (2) determine the healing response to the endovascular incisions; and (3) compare angiographie results obtained with standard and cutting balloons.