Medtronic’s Hugo Robot Will Improve GYN Surgery

​Multiple sources have reported that Medtronic submitted its surgical robot to the FDA. If it gets FDA approval, physicians will be able to use Hugo for gynecological procedures. As it stands, Hugo has passed several benchmarks in urological procedures, with researchers preparing for trials to use the robot for hernia and gynecological surgeries.

In general, robotic-assisted surgeries involve a trained surgeon who sits at a computer console several feet from the patient. The computer gives the physician a 3D high-definition view of the surgical site and contains hand controls, which the physician uses to move the arms above the operating table. An assistant stands near the operating table to monitor the robotic arms, which contain cameras and tools for clamping, cutting, and suturing the incision.

Physicians are currently using robotic-assisted surgery for procedures like hysterectomies, uterine fibroid removal, endometriosis treatment, and pelvic organ prolapse repair. The benefits for patients include less bleeding, a reduced risk of infection, and smaller scars compared to traditional surgery. For surgeons, the technology provides greater precision by reducing tremors caused by long tool usage and offers a detailed view of the surgical area.

In late April 2025, Medtronic submitted Hugo to the Food and Drug Administration (FDA) to get approval for use in urological procedures with the intention of expanding this approval for hernia and gynecological procedures. The Hugo Robot is a multi-quadrant, modular surgical tool with advanced 3D visualization, wristed instruments, and integrated video capture features that function through Touch Surgery Enterprise.

While not cleared for gynecological procedures, the urological trials also show promise for the tool's use in gynecology. The study, titled Expand URO FDA investigational advice exemption, involved testing the device on 137 patients with the Hugo system. Eleven surgeons used Hugo at six hospitals nationwide to perform three types of urological surgeries: prostatectomies (removing the prostate), nephrectomies (removing the kidneys), and cystectomies (removing the bladder). The surgeons performed procedures on patients with renal and bladder tumors and prostate cancer.

Researchers found that using the Hugo instrument in robotic-assisted surgery resulted in a success rate meeting FDA requirements. Some procedures experienced grade three or higher complications, where grades three and above indicate severe issues affecting daily activities. Hugo met primary safety endpoints, confirming its effectiveness as a treatment. The trials showed a 98.5 percent success rate, exceeding the trial's success rate goal of 85 percent.

How does this all connect with Hugo's use in gynecology? In a second-quarter meeting, Medtronic reported that it had intended to expand trials in this area, along with hernia. The company completed enrollment trials for Hugo's use to treat these conditions at the beginning of 2025.

Medtronic CEO and Chair Geoff Martha stated that the company is working to establish itself as a leader in robotic surgery. James Porter, MD, Chief Medical Officer at Medtronic, stated that the urological trials were an important milestone in providing surgeons nationwide with options in robotic surgery. Furthermore, surgeons want to give patients the best care, and robotic surgery has made this possible. For more information on the Hugo trial's progress, visit the Medtronic site at www.medtronic.com/in-en/index.html.

Alex Culbreth GA

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