Medtronic has initiated the Embrace Gynecology study in the US to assess the Hugo robotic-assisted surgery (RAS) system’s performance in gynaecological surgeries.
The investigational device exemption (IDE) study’s inaugural procedures, total hysterectomies, were concluded at AHN West Penn Hospital in Pittsburgh, US, by study surgeons Dr Eirwen Miller and Dr Sarah Crafton, from the Allegheny Health Network.
The multicentre prospective trial focuses on the effectiveness and safety of the robotic system in various hysterectomy procedures, including those for patients with malignancies.
Embrace Gynecology national principal investigator and Duke University Obstetrics and Gynecology associate professor Dr Emma Rossi said: “We are excited to initiate this important clinical study, which aims to investigate surgical treatment options for women in the US.
“In my experience, women facing a gynaecologic diagnosis want two things: to effectively treat their condition, and to get back to their full lives as quickly as possible. Robotic-assisted surgery helps make that possible.”
The study aims to recruit up to 70 subjects and will take place across a maximum of five hospitals in the country. It represents the third IDE trial for the Hugo RAS system in the US.
Previous trials, Expand URO and Enable Hernia Repair, have achieved their primary endpoints for safety and effectiveness.
Additionally, positive outcomes from a prospective trial sponsored by Medtronic on the Hugo RAS system for benign gynaecologic procedures were presented at the Society of Robotic Surgery congress in France in July.
Medtronic is currently awaiting the Food and Drug Administration’s review of its first US submission for a urology indication, expected within the present fiscal year.
Subsequent indications for gynaecology and hernia repair will follow.
Globally, the system is being used clinically in more than 30 nations across five continents.
While commercially available in certain regions, its approval and market availability are subject to the regulatory requirements of each country.
In the US, the system remains investigational and is not yet available for sale.
In July 2025, Medtronic received EU CE mark approval for its LigaSure RAS vessel-sealing instrument, which is designed for use with the Hugo RAS system.
