FDA grants Breakthrough Device Designation to Avvio Enhanced Lithotripsy System

The FDA has granted breakthrough device designation to the Avvio Enhanced Lithotripsy System (ELS) as a minimally invasive treatment for ureteral stones, Avvio Medical announced in a news release.¹

Breakthrough device designation is granted to devices that represent a meaningful advance in safety or effectiveness. With this designation, the development pathway for the Avvio ELS can benefit from more frequent feedback from the FDA as well as accelerated review.

According to Avvio, the company plans to submit a de novo application for clearance of the device 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,” said Paul Molloy, CEO of Avvio Medical, in the news release.¹ “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 Avvio ELS “introduces microbubble enhanced acoustic cavitation lithotripsy,” according to Avvio Medical. The company also emphasized that the device has the potential to reduce disparities in care by enabling treatment outside of the operating room.

“The Avvio ELS enables stone treatments…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,” the company explained.

Avvio ELS Study

The Avvio ELS is currently under investigation in a pivotal investigational device exemption study (NCT06942949) in the US. Overall, the prospective, single-arm trial is assessing the safety and performance of the device in fragmentation of urinary stones in the ureter. In total, the trial planned to enroll up to 101 adult patients with urinary stones across 20 clinical trial sites.

To be eligible for enrollment, participants needed to have 1 urinary stone that is within the ureter, sized between 5mm and 10mm, present on a CT scan, and indicated for shockwave lithotripsy per American Urological Association 2016 guidelines. Patients are not eligible for enrollment if they have non-calcium based stones, untreated urinary tract infection, or abnormal kidney function.

All participants in the trial will undergo the ELS procedure and be assessed at 30 days post-treatment. The primary outcome measure for the study is stone free status (zero fragments) or the presence of only stone fragments small enough to pass spontaneously (4 mm or smaller) per CT assessment at the 30-day time point. The investigators will also assess changes in pain, quality of life, and return to normal daily activities/work.

REFERENCES

1. Avvio Medical receives FDA Breakthrough Device Designation for the Avvio Enhanced Lithotripsy System (ELS). News release. Avvio Medical, Inc. October 28, 2025. Accessed October 29, 2025. https://www.businesswire.com/news/home/20251028004342/en/Avvio-Medical-Receives-FDA-Breakthrough-Device-Designation-for-the-Avvio-Enhanced-Lithotripsy-System-ELS

2. Evaluation of Enhanced Lithotripsy System (ELS) in the treatment of urinary stones, a pivotal trial (ELS). ClinicalTrials.gov. Last updated October 1, 2025. Accessed October 29, 2025. https://clinicaltrials.gov/study/NCT06942949