FDA Grants Breakthrough Device Designation to Avvio Medical’s Advanced Lithotripsy System

Avvio Medical, Inc., has received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) for its Avvio Enhanced Lithotripsy System (ELS). 

The designation recognises the system’s potential to improve outcomes, reduce complications, and increase access to less invasive, anaesthesia-free kidney stone treatments for millions of patients affected by ureteral stones each year.

The FDA’s Breakthrough Device programme is designed to expedite the development and review of medical technologies that represent significant advances in safety or effectiveness. 

The designation allows Avvio Medical to engage closely with the FDA through a priority review process as the company finalises its clinical studies and prepares for a De Novo submission planned for early 2026.

The Avvio ELS enables stone treatments to be performed outside the operating room, including in outpatient and ambulatory surgery centres, and eventually in doctors’ offices. 

By reducing the need for general anaesthesia and stenting, the system aims to lower costs, shorten recovery times, and expand access to care, particularly for older patients.

Avvio is currently conducting a pivotal clinical trial under an active Investigational Device Exemption (IDE) and plans to launch the ELS commercially in the United States following FDA clearance in 2026.