Lithotripter gains FDA approval; urease inhibitor now available in U.S.
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.
From evidence to practice: Dr. Makarov discusses implementation science in urology
July 25th 2024“What our major contribution is, I think as urologists doing implementation science, is determining the important questions, which we are particularly well-suited to do because we're taking care of the patients,” says Danil V. Makarov, MD, MHS.
