Lithotripter gains FDA approval; urease inhibitor now available in U.S.

September 10, 2009

EDAP TMS SA has received FDA clearance to market its newly designed Sonolith I-Sys lithotripter in the United States.

EDAP TMS SA has received FDA clearance to market its newly designed Sonolith I-Sys lithotripter in the United States.

The integrated lithotripter utilizes the company's patented electroconductive technology. EDAP said the device's superior x-ray and ultrasound imaging systems and user-friendly features have contributed to positive treatment outcomes in Europe, where the product was launched in late 2007.

In related news, Mission Pharmacal has announced that acetohydroxamic acid (Lithostat), a urease inhibitor available for urea-splitting urinary infections in association with struvite stones, is now available at U.S. pharmacies nationwide.

Mission said it has successfully contracted with a new supplier of acetohydroxamic acid to re-introduce Lithostat on the market.

In single clinical trials, the product allowed successful antibiotic treatment of urea-splitting infections after surgical removal of struvite stones in patients not cured by 3 months of antibacterial treatment alone. It also reduced the rate of stone growth in patients who were not candidates for surgical removal of stones, according to the company.