FDA Grants Breakthrough Device Designation to Avvio Medical

The U.S. Food and Drug Administration has granted Breakthrough Device Designation to the Avvio Enhanced Lithotripsy System, the microbubble enhanced acoustic cavitation lithotripsy platform being developed by portfolio company Avvio Medical for the treatment of ureteral stones.

Per the company, the Breakthrough Device 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 to collaborate more closely with FDA reviewers as it finalizes its clinical program and prepares for a De Novo submission in early 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.”

The company notes that the FDA also considers health equity and access in its Breakthrough decisions. The Avvio ELS is designed to enable stone treatment outside the operating room, in outpatient and ambulatory surgery center settings and eventually in physician offices, eliminating the routine need for general anesthesia or stenting. The system is described as suitable for ambulatory surgery centers and cystoscopy suites without requiring general anesthesia, fluoroscopy, or costly capital equipment. The company states that stone disease incidence is disproportionately represented in the Medicare-aged population.

Avvio is conducting its pivotal ELS clinical trial in the United States under an active IDE, with plans for U.S. commercial launch following FDA clearance in 2026.