Avvio Medical announced the successful treatment of the first patients using its investigational Enhanced Lithotripsy System (ELS), a pioneering advancement in kidney stone therapy. This milestone follows the company’s recent approval of its Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA), marking the official launch of its clinical trial.
“Our team has developed a world-class solution poised to redefine kidney stone treatment,” said Paul Molloy, President and Chief Executive Officer of Avvio Medical. “The AVVIO ELS is designed to dramatically improve patient outcomes and streamline current treatment protocols. We’re excited to begin this pivotal trial.”
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The AVVIO Enhanced Lithotripsy System introduces a novel mechanism of action that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy for ambulatory surgery centers (ASCs) and cystoscopy suites, without the need for general anesthesia, fluoroscopy, or costly capital equipment. This innovative approach offers meaningful clinical and economic advantages for both patients and providers.
“After years of research and development, we are excited to initiate our clinical trial to evaluate this new technology,” said Dr. Marshall Stoller, co-founder of Avvio Medical. “Our goal is to explore its potential to improve kidney stone treatment and patient outcomes.”
