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Related Experiment Videos

Clinical experience with the Storz Modulith SL 20 lithotriptor

A E Finkbeiner1, J E Fowler, R J Kahnoski

  • 1Department of Urology, University of Arkansas for Medical Sciences, Little Rock, USA.

Southern Medical Journal
|May 23, 1998
PubMed
Summary

The Storz Modulith SL 20 lithotriptor is a safe and effective device for treating kidney and ureteral stones. This study confirmed its high success and stone-free rates with minimal adverse events in an outpatient setting.

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Area of Science:

  • Urology
  • Medical Devices
  • Nephrology

Background:

  • Evaluation of the Storz Modulith SL 20 lithotriptor.
  • Pre-market approval study conducted for the Food and Drug Administration (FDA).

Purpose of the Study:

  • To assess the safety and effectiveness of the Storz Modulith SL 20 lithotriptor.
  • Determine the device's efficacy in treating renal and ureteral calculi.

Main Methods:

  • Study protocol included a maximum of 2,000 shock waves per treatment.
  • No more than three treatments were administered per patient.
  • Defined safety and effectiveness parameters were strictly followed.

Main Results:

  • Achieved an overall success rate of 74.6%.

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  • Reported a stone-free rate of 63.6%.
  • No clinically or statistically significant adverse trends were observed during acute or follow-up periods.
  • Conclusions:

    • The Storz Modulith SL 20 lithotriptor is demonstrated to be safe and effective.
    • The device is suitable for treating renal and ureteral calculi.
    • Outpatient treatment with intravenous sedation/analgesia is feasible.