Successful experimental and clinical experience with thrombus ablation has been attained with high-power acoustic energy delivered in a catheter. The goal of this study was to investigate the feasibility of noninvasive thrombus ablation by focused high-power acoustic energy. The source for high-power acoustic energy was a shock-wave generator in a water tank equipped with an acoustic lens with a fixed focal point at 22.5 cm. Thrombus was prepared in vitro, weighed (0.24 +/- 0.08 g), and inserted in excised human femoral artery segments. The arterial segments wer ligated, positioned at the focal point and then randomized into either test (n = 8) or control (n = 7). An x-ray system verified the 3-dimensional positioning of the arterial segment at the focal point. A 5 MHz ultrasound imaging system continuously visualized the arterial segment at the focal point before, during and after each experiment. The test segments were exposed to shock waves (1,000 shocks/24 kv). The arterial segment content was then flushed and the residual thrombus weighed. The arterial segment and thrombus were fixed and submitted to histologic examination. The test group achieved a significant ablation of thrombus mass (0.25 +/- 0.15 vs 0.07 +/- 0.003 g; p = 0.0001) after application of shock waves. Arterial segments showed no gross or microscopic damage. Ultrasound imaging revealed a localized (1.9 +/- 0.5 cm2), transient (744 +/- 733 ms), cavitation field at the focal point at the time of application of focused shock waves. Thus, focused high-power acoustic energy can effect noninvasive thrombus ablation without apparent damage to the arterial wall.(ABSTRACT TRUNCATED AT 250 WORDS)