Medtronic submits Hugo surgical robot to FDA, meets endpoints

Medtronic

(NYSE: MDT)
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announced today that it recently submitted its Hugo surgical robot platform to the FDA for a urologic indication.

The medtech giant said it submitted its soft tissue robotics platform in the first quarter of calendar 2025. It expects the submission to propel it toward its planned entrance into the U.S. surgical robotics market. This falls in line with the company’s expectation shared last fall for an early 2025 submission.

Medtronic said on its November second-quarter earnings call that it planned to add more clinical studies earlier this year. It seeks to expand Hugo’s indications to hernia and gynecology. Medtronic completed enrollment in trials for both of those spaces earlier this year.

Hugo is a modular, multi-quadrant platform designed for various surgical procedures. It features wristed instruments, 3D visualization and surgical video capture options in Touch Surgery Enterprise. Medtronic first unveiled Hugo in September 2019 as a potential competitor to long-time industry leader Intuitive Surgical.

[For more on the wide world of surgical robotics, download our free special report on the space.]

While this would mark Hugo’s entry into the U.S., it’s currently in clinical use elsewhere. Its use spans more than 25 countries across five continents.

Chair and CEO Geoff Martha said last November that, when it comes to surgical robotics, Medtronic wants to establish itself as a leader.

“We’re absolutely committed to this … not just being a part of this, but helping to lead it, as we do in spine,” he said.

FDA IDE study meets endpoints to go along with Medtronic Hugo submission

Medtronic said the Expand URO FDA investigational device exemption (IDE) study of Hugo met both its primary safety and effectiveness endpoints. The company labeled it the largest IDE study for robotic-assisted urologic surgery ever conducted.

Expand URO included 137 patients who underwent procedures using the Hugo system. Dr. Michael Abern, national principal investigator and urologic surgeon at Duke University Hospital in Durham, North Carolina, presented findings today at the American Urologic Association (AUA) annual meeting in Las Vegas.

“The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery,” said Dr. Abern. “Having performed the first case in the Expand URO clinical study, it’s incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery.”

A deeper look at the data presented at AUA

Expand URO took place through 11 surgeons at six U.S. hospitals. They performed three types of urologic procedures. Those were prostatectomies (prostate removal, 55 total procedures), nephrectomies (kidney removal, 53) and cystectomies (bladder removal, 29). Common patient cohorts had prostate cancer in prostatectomy, renal tumors in nephrectomy and bladder tumors in cystectomy.

Medtronic said its study had a high degree of rigor, consistent with FDA premarket requirements. It included prospective enrollment and data collection and independent event adjudication by a clinical events committee. The study had data monitoring and strong follow-up compliance, too, with about 98% of patients completing 30-day follow-up. Investigators plan to follow all patients for five years.

The study produced rates of grade 3 or higher complications of 3.7% (prostatectomy), 1.9% (nephrectomy) and 17.9% (cystectomy). These came in favorably below the performance goals (20%, 20% and 45%, respectively). This met the primary safety endpoint for the study.

For effectiveness. the 98.5% surgical success rate came in well ahead of the performance goal of 85%. Investigators reported two conversions — one related to the device and the other related to patient anatomy.

“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 Dr. James Porter, chief medical officer, Robotic Surgical Technologies and Digital Technologies at Medtronic. “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.”