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The clinical introduction of a third generation lithotriptor: Modulith SL 20
K U Köhrmann1, J J Rassweiler, M Manning
1Department of Urology, Mannheim Hospital, Germany.
The Journal of Urology
|May 1, 1995
Summary
The Modulith SL 20 lithotriptor effectively broke down kidney stones using combined ultrasound and fluoroscopy. This advanced system improved treatment time and stone-free rates for upper urinary tract stones.
Area of Science:
- Urology
- Medical Devices
- Nephrology
Background:
- Extracorporeal shock wave lithotripsy (ESWL) is a common treatment for kidney stones.
- Previous lithotriptors had limitations in stone localization and treatment efficacy.
- The Modulith SL 20 was developed as a third-generation lithotriptor.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of the Modulith SL 20 lithotriptor.
- To assess the impact of system improvements on stone disintegration and treatment outcomes.
- To compare the Modulith SL 20's performance with other lithotripters.
Main Methods:
- Phased clinical introduction of the Modulith SL 20 (Phase 1: ultrasound only, Phase 2: fluoroscopic localization, Phase 3: increased voltage).
- Inclusion of 698 patients undergoing extracorporeal shock wave lithotripsy.
- Assessment of stone disintegration, treatment time, stone-free rates, and complications.
Main Results:
- Phase 3 demonstrated successful disintegration of stones throughout the upper urinary tract.
- Treatment time decreased from 52 to 39 minutes with improved efficiency.
- A 91% stone-free rate was achieved with a 23% retreatment rate and minimal complications (1.8% fluid collection/bleeding).
Conclusions:
- The Modulith SL 20, with its enhanced localization and shock wave energy, offers high efficacy for treating upper urinary tract stones.
- The device demonstrated improved treatment efficiency and a favorable safety profile.
- The Modulith SL 20 shows a high efficacy quotient compared to other lithotripters.