Irish firm Medtronic has started a US clinical study to evaluate the safety and effectiveness of its Hugo robotic-assisted surgery (RAS) in gynaecological procedures.

The first procedures, total hysterectomies, in the Embrace Gynecology investigational device exemption (IDE) trials were completed at AHN West Penn Hospital in Pittsburgh, Pennsylvania, by Sarah Crafton and Eirwen Miller, Embrace Gynecology study surgeons at Allegheny Health Network.

Embrace Gynecology is a prospective multicentre study to evaluate the safety and effectiveness of the Hugo RAS system when used during hysterectomy procedures (radical, modified radical or total hysterectomies), inclusive of those being treated for malignancies. The study will enrol up to 70 patients across five US hospitals.

“We are excited to initiate this important clinical study, which aims to investigate surgical treatment options for women in the USA,” said Emma Rossi, Embrace Gynecology national principal investigator and associate professor of obstetrics and gynaecology at Duke University in Durham, North Carolina. “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 National Cancer Institute estimates that nearly 111,000 US women will have been diagnosed with gynaecological cancer by the end of 2025, while hundreds of thousands more will experience benign conditions such as fibroids or abnormal bleeding. Surgery is a common treatment for many of these gynaecological conditions and, for some cancers, such as uterine (endometrial) cancer, it is usually the first and primary treatment.

As a form of minimally invasive surgery, robotic-assisted procedures offer patients fewer complications, shorter hospital stays and faster return to normal activities than open surgery.

“The study name, Embrace, reflects our deeply felt compassion and care for patients and our commitment to providing access to less invasive treatment options for women,” said James Porter, chief medical officer at Medtronic. “We are grateful for the strong partnership with clinical teams at our study sites and share their excitement about this rigorous scientific study that is helping to usher in a new era of choice for patients in the USA.”

Embrace Gynecology becomes the third IDE clinical study for Hugo RAS in the USA, demonstrating Medtronic’s commitment to obtaining multiple indications for its Hugo RAS system. The two other studies — Expand URO and Enable Hernia Repair — both met their primary safety and effectiveness endpoints.

Also, in July, positive results from a Medtronic-sponsored prospective study of the Hugo RAS system in benign gynaecologic procedures outside the USA were shared at the Society of Robotic Surgery congress in Strasbourg, France.

The company’s first US submission, for a urology indication, is under review by the FDA and is expected later in the company’s current fiscal year, followed by planned indication expansions into hernia repair and gynaecology.

The Hugo RAS (medtronic.com/hugo) system is in clinical use in more than 30 countries on five continents, with nearly 300 independent publications to date. It is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance or market availability. In the EU, the system is CE marked. In the USA, it is an investigational device not for sale.

Headquartered in Galway, Ireland, Medtronic (www.Medtronic.com) is a healthcare technology company with a team of 95,000 people across more than 150 countries. Its technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools and patient monitoring systems.