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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
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.
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%.
- 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.