title: Clinical experience with the Storz Modulith SL 20 lithotriptor.
abstract: 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.
authors.affiliation: Department of Urology, University of Arkansas for Medical Sciences, Little Rock, USA.
authors.forename: A E
authors.initials: AE
authors.lastname: Finkbeiner
authors.forename: J E
authors.initials: JE
authors.lastname: Fowler
authors.forename: R J
authors.initials: RJ
authors.lastname: Kahnoski
authors.forename: F A
authors.initials: FA
authors.lastname: Klein
mesh_terms: 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*