Avvio Medical has announced the successful treatment of its first patients using the company’s investigational Enhanced Lithotripsy System (ELS), signaling a new era in kidney stone management. The launch follows FDA approval of an Investigational Device Exemption (IDE), enabling the company to initiate a pivotal clinical trial.

The AVVIO ELS introduces a novel mechanism designed to transform kidney stone treatment by shifting care from traditional operating rooms to outpatient and office-based settings. The system enables a single-session, minimally invasive therapy that can be performed in ambulatory surgery centers and cystoscopy suites—without requiring general anesthesia, fluoroscopy, or expensive capital equipment.

Executives at Avvio Medical emphasized the ELS system's potential to simplify care delivery while enhancing clinical and economic outcomes. Dr. Marshall Stoller, the company’s co-founder, stated that the trial aims to evaluate the system’s real-world effectiveness in improving treatment workflows and patient recovery.

The development marks a major milestone for Avvio Medical, formerly Applaud Medical, as it progresses toward offering a more accessible and patient-friendly solution for kidney stone management.

MedTech Spectrum's Summary:

• Avvio Medical treats first patients in a clinical trial using its Enhanced Lithotripsy System (ELS).

• ELS enables kidney stone treatment in outpatient settings without general anesthesia or fluoroscopy.

• The trial aims to evaluate the system’s ability to improve outcomes and reduce procedural complexity