Effectiveness and safety of ultrasonic atherosclerotic plaque ablation: in vitro investigation.

Ultrasound energy was applied to 137 segments of human cadaver atherosclerotic arteries, 90 with calcified and 47 with noncalcified atheromatous plaque, and to 100 segments of healthy swine aorta. The average depth of penetration was dependent on the forward force of the ultrasonic probe, the duration of treatment, and the degree of atherosclerosis. There was one perforation of a fibrous plaque using a forward force of 2 Newton and 45 sec of application time. Injury of healthy intima was minimal. It is concluded that catheter-delivered ultrasound is effective and safe for the disintegration of atherosclerotic plaques. Presently, the main limitations of the system are the lack of flexibility and steerability.