Avvio Gains FDA Breakthrough Status for Enhanced Lithotripsy System

Avvio Medical, a clinical-stage company developing next-gen kidney stone treatment tech, has received U.S. Food and Drug Administration (FDA) breakthrough device status for its Avvio Enhanced Lithotripsy System (ELS).

The technology introduces microbubble enhanced acoustic cavitation lithotripsy that helps move kidney stone treatments out of the traditional operating room and into more accessible outpatient locations.

This designation highlights the Avvio ELS system’s potential to improve outcomes and reduce complications. It also aims to expand access to minimally invasive, anesthesia-sparing kidney stone care for the millions of patients suffering from ureteral stones each year.

Avvio Medical can now collaborate more closely with FDA reviewers as its finalizes its clinical program and gears up for a de novo submission early next year.

The Avvio ELS allows stone treatments outside the operating room, in outpatient and ambulatory surgery center (ASC) settings and eventually doctors’ offices. This removes the need for general anesthesia or stenting.

The approach, according to the company, supports value-based care, lowers costs of procedures, and cuts patient recovery times. Avvio is conducting its pivotal ELS trial in the U.S. under an active investigational device exemption (IDE) with plans for U.S. launch following FDA clearance in 2026.

“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.”

In July, the company achieved ISO 13485:2016 certification after an initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio’s compliance with international standards for medical device quality management systems.