Medtronic revealed that its Expand URO investigational device exemption (IDE) clinical study met both primary and safety effectiveness endpoints.

Expand URO is touted as the largest such study for robotic-assisted urologic surgery every conducted. The study included 137 patients who underwent urologic procedures using the Hugo robotic-assisted surgery (RAS) system.

11 surgeons across six hospitals in the U.S. performed three types of urologic procedures—prostatectomies, nephrectomies, and cystectomies. Common patient cohorts were were prostate cancer in prostatectomy, renal tumors in nephrectomy, and bladder tumors in cystectomy.

The 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. The study’s 98.5% surgical success rate was well above the performance goal of 85%.

Medtronic also submitted the Hugo RAS system to the U.S. Food and Drug Administration (FDA) for a urologic indication in Q1 2025. In February, the company finished enrollment in its hernia and benign gynecology studies and earned approval to begin a new study including oncologic gynecology procedures.

Hugo RAS is in clinical use in over 25 countries across five continents, with more than 200 independent papers published to date.

The system has a flexible, modular form factor and open surgeon console that supports communication among the surgical team. It’s paired with Medtronic’s Touch Surgery ecosystem as well.

“The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology,” said James Porter, MD, chief medical officer, of Medtronic’s Robotic Surgical Technologies and Digital Technologies business, and a urologic surgeon at Swedish Medical Center in Seattle, Wash. “Surgeons want to deliver the best care to our patients and robotic technology is key to making that possible today by enabling minimally invasive surgery and leveraging technology that is shaping the future of surgery.”