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Calyxo’s CVAC System is FDA-cleared and commercially available for minimally invasive kidney stone removal. Clinical studies—including randomized controlled trials—demonstrate that the SURE procedure using CVAC achieves superior stone clearance rates compared to standard ureteroscopy, with 97% volumetric clearance reported and over 10,000 patients treated as of April 2025. The second-generation system was launched in 2024 and has seen rapid adoption among urologists.
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