Clinical Experience With the Storz Modulith SL 20 Lithotriptor
AbstractAbstract Background.A Food and Drug Administration pre-market approval study evaluated the safety and effectiveness of the Storz Modulith SL 20 lithotriptor. Methods.Protocol was a maximum of 2,000 shock waves per treatment and no more than three treatments per patient. Safety and effectiveness parameters were defined and followed. Results.The overall success rate was 74.6% with a stone-free rate of 63.6%. No clinically or statistically significant adverse trends were noted acutely or in follow-up. Conclusion.The Storz Modulith SL 20 lithotriptor is a safe and effective device to treat renal and ureteral calculi in an outpatient setting using intravenous sedation/analgesia.
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