Avvio Medical, Inc., a clinical-stage medical device company developing next-generation kidney stone treatment technologies, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) to the Avvio Enhanced Lithotripsy System (ELS). The designation highlights the system’s potential to improve outcomes, reduce complications, and expand access to minimally invasive, anesthesia-sparing kidney stone care for millions of patients affected by ureteral stones each year.
The FDA Breakthrough Device Designation program is designed to accelerate patient access to technologies that represent a meaningful advance in safety or effectiveness. The designation provides priority engagement and an accelerated review pathway, allowing Avvio Medical to collaborate more closely with FDA reviewers as it finalises its clinical program and prepares for a De Novo submission in early 2026.
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“The FDA’s recognition of Avvio ELS as a Breakthrough Device marks a significant milestone for our company and for the patients who stand to benefit from more accessible, less invasive treatment,” said Paul Molloy, CEO of Avvio Medical. “This designation not only validates the strength of our clinical evidence but also gives us a clear, collaborative path with the FDA as we move toward De Novo submission and eventual market launch.”
The FDA also considers health equity and access in its Breakthrough decisions, recognizing innovations that can reduce disparities in care. The Avvio ELS enables stone treatments outside the operating room, in outpatient and ambulatory surgery center (ASC) settings and eventually in doctors’ offices, eliminating the routine need for general anesthesia or stenting. This approach supports value-based care, lowers procedural costs, and shortens patient recovery times – all while increasing availability of treatment in community settings and broadening access for the Medicare-aged population which is disproportionately represented in stone disease incidence.
Avvio Medical is currently conducting its pivotal ELS clinical trial in the United States under an active IDE, with plans for a U.S. commercial launch following FDA clearance in 2026.
