SAN FRANCISCO– Avvio Medical, formerly known as Applaud Medical, has successfully treated the first patients with its investigational Enhanced Lithotripsy System (ELS), marking the official start of a clinical trial following FDA approval of the company’s Investigational Device Exemption (IDE).
The AVVIO ELS represents a significant shift in kidney stone treatment, offering a minimally invasive therapy that can be delivered in outpatient and office-based settings rather than traditional hospital operating rooms. The system eliminates the need for general anesthesia, fluoroscopy, or expensive capital equipment, potentially lowering costs and improving access for patients.
“Our team has developed a world-class solution poised to redefine kidney stone treatment,” said Paul Molloy, President and CEO of Avvio Medical. “The AVVIO ELS is designed to improve patient outcomes and streamline treatment protocols, and we’re excited to begin this pivotal trial.”
The trial launch follows years of research and development aimed at creating a more efficient and patient-friendly approach to managing kidney stones. Dr. Marshall Stoller, co-founder of Avvio Medical, noted that the trial marks a critical step in validating the technology’s clinical and economic benefits.
“After years of development, we are thrilled to initiate this study and explore the potential of this new therapy to improve kidney stone care,” said Dr. Stoller.
Avvio’s new approach could bring kidney stone treatment to ambulatory surgery centers and cystoscopy suites nationwide, potentially transforming how and where patients receive care.
