Ultrasonic Thrombus Ablation: In Vitro Assessment of a Novel Device for Intracoronary Use

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Abstract
An ultrasonic thrombolysis device designed for intracoronary use was developed and evaluated in vitro to assess efficacy in achieving clot ablation without deleterious effects, such as heat generation and production of large particles during clot ablation. Studies on 31 samples with a bench-top version demonstrated that clot ablation was rapid (typically 2 mL in under 2 minutes) and no macroscopic particles were released. The fluid produced did not reclot. Studies with a clinical version of the device that can be passed through a 10 Fr PTCA guiding catheter confirmed that clot ablation was rapidly achieved. Little particulate material was produced and the maximum temperature achieved did not exceed 52 degrees C. The device functions well in vitro, releasing little particulate material and causing limited local heating. It seems suitable for intracoronary use and will undergo further in vivo testing.