Clinical experience with the Storz Modulith SL 20 lithotriptor.
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.


CONCLUSIONS
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.
Finkbeiner
A E
AE
Department of Urology, University of Arkansas for Medical Sciences, Little Rock, USA.
Fowler
J E
JE
Kahnoski
R J
RJ
Klein
F A
FA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001145:Arrhythmias, Cardiac / Q000209:etiology; D015716:Electrocardiography, Ambulatory / Q000295:instrumentation; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D006801:Humans; D007669:Kidney Calculi / Q000628:therapy*; D007677:Kidney Function Tests; D008096:Lithotripsy / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence; D014514:Ureteral Calculi / Q000628:therapy*