Medtronic begins U.S. clinical study of Hugo robot for gynecological surgery

GALWAY, Ireland - Medtronic plc (NYSE:MDT), a prominent player in the Healthcare Equipment & Supplies industry with a market capitalization of $126 billion, has initiated the Embrace Gynecology clinical study to evaluate its Hugo robotic-assisted surgery system for gynecological procedures in the United States, according to a company press release. According to InvestingPro analysis, the company maintains strong financial health with annual revenue of $34.2 billion.

The investigational device exemption (IDE) study will assess the safety and effectiveness of the Hugo system in hysterectomy procedures, including those treating malignancies. The first procedures, total hysterectomies, were completed at AHN West Penn Hospital in Pittsburgh by Dr. Sarah Crafton and Dr. Eirwen Miller. This expansion aligns with Medtronic’s robust financial position, reflected in its "GREAT" overall financial health score from InvestingPro.

The study will enroll up to 70 patients across a maximum of five U.S. hospitals. Dr. Emma Rossi from Duke University serves as the national principal investigator.

"In my experience, women facing a gynecologic diagnosis want two things: to effectively treat their condition, and to get back to their full lives as quickly as possible," Dr. Rossi stated in the release.

The National Cancer Institute estimates nearly 111,000 U.S. women will be diagnosed with gynecological cancer by the end of 2025. Robotic-assisted procedures, as a form of minimally invasive surgery, can offer patients fewer complications, shorter hospital stays, and faster recovery compared to open surgery.

This marks Medtronic’s third IDE clinical study for the Hugo system in the U.S., following the Expand URO and Enable Hernia Repair studies, both of which met their primary endpoints. The company expects its first U.S. submission for a urology indication later in its current fiscal year.

The Hugo system is currently in clinical use in more than 30 countries across five continents but remains an investigational device not for sale in the United States. With the stock trading near its 52-week high and showing strong momentum, investors can access comprehensive analysis and 10+ additional ProTips through InvestingPro’s detailed research reports.

In other recent news, Medtronic has successfully closed a €1.5 billion senior notes offering, which consists of €750 million in 2.950% senior notes due 2030 and €750 million in 4.200% senior notes due 2045. The company plans to use the net proceeds of approximately €1.49 billion to repay existing debt, specifically Medtronic Global Holdings S.C.A.’s senior notes due in 2025. Additionally, Medtronic has received U.S. Food and Drug Administration approval for its Altaviva device, a minimally invasive therapy for treating urge urinary incontinence. This device is designed to restore communication between the bladder and brain, improving bladder control.

In terms of analyst insights, Piper Sandler has maintained a Neutral rating on Medtronic, highlighting ongoing challenges in the company’s surgical business due to market shifts toward robotic procedures and GLP-1 medications. These developments come amid Medtronic’s efforts to navigate pressures in its advanced surgical business, which includes stapling and vessel sealing products.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.