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# Medtronic Files PMA for Hugo Urology Surgical Robot
- URL: https://www.fdaweb.com/medtronic-files-pma-for-hugo-urology-surgical-robot/
- Published: 2025-04-28T12:00:00.000Z
- Updated: 2026-09-14T15:10:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159077

Medtronic has submitted a PMA for its Hugo robotic-assisted surgery (RAS) system for a urologic indication. The submission is based on data from the company’s Expand URO clinical study, which met both primary safety and effectiveness endpoints. “The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo robotic-assisted surgery (RAS) system,” the company says.

Regarding effectiveness, the study showed a 98.5% surgical success rate, which was well above the performance goal of 85%, Medtronic says. Safety data showed rates of Grade 3 or higher complications (3.7% prostatectomy, 1.9% nephrectomy, and 17.9% cystectomy) were favorably below the performance goals (20% prostatectomy, 20% nephrectomy, and 45% cystectomy, respectively), it says.

In February, the company shared that it completed enrollment in both its hernia and benign gynecology (GYN) studies and received approval to start a new clinical study including oncologic GYN procedures. The study findings are intended to support planned FDA submissions for additional indications beyond urology for the Hugo RAS system.