#United States #Pittsburgh, PA #Medtronic #Hugo RAS #Embrace Gynecology

Medtronic Launches Groundbreaking Clinical Study

Medtronic plc, headquartered in Galway, Ireland, has announced the initiation of its Embrace Gynecology investigational device exemption (IDE) clinical study, which aims to evaluate the safety and effectiveness of the Hugo™ robotic-assisted surgery (RAS) system in gynecological procedures. This innovative robotic system focuses specifically on improving treatment options for women undergoing hysterectomies, a common procedure often required in the management of various gynecological conditions.

Significance of the Study

The Embrace Gynecology study is particularly crucial as recent statistics from the National Cancer Institute indicate that nearly 111,000 women in the U.S. will be diagnosed with gynecological cancers by the end of 2025. Additionally, a significant number will face benign conditions, such as fibroids and abnormal bleeding, requiring surgical intervention. Robotic-assisted surgery is increasingly being recognized for its ability to offer patients several advantages over traditional open surgeries, including fewer complications, reduced hospital stays, and quicker returns to daily activities.

The first total hysterectomy procedures were successfully carried out at AHN West Penn Hospital in Pittsburgh, PA, by Dr. Sarah Crafton and Dr. Eirwen Miller, who are leading the study along with several other medical professionals.

Objectives and Design of the Study

The primary objective of the Embrace Gynecology study is to evaluate the effectiveness of the Hugo RAS system during various types of hysterectomy procedures. The study targets enrolling up to 70 patients across five hospitals in the U.S., focusing on radical, modified radical, and total hysterectomies.

Dr. Emma Rossi, the national principal investigator for the study and an associate professor of Obstetrics and Gynecology at Duke University, emphasized the need for effective treatment options that allow patients to resume their lives promptly. She noted that robotic-assisted surgery facilitates this goal, presenting a less invasive route to treatment.

Expanding Surgical Options

The study is designed to advance surgical treatment for women by providing new methods of approaching gynecological surgeries. Embrace Gynecology is particularly notable as it marks Medtronic’s third IDE clinical study for the Hugo RAS system in the U.S., demonstrating the company’s commitment to broadening its technological applications for various indications.

Previously, Medtronic conducted two other successful IDE studies—Expand URO and Enable Hernia Repair—both of which achieved their primary safety and effectiveness endpoints. The company continues to maintain a robust pipeline, with additional studies underway, including international studies that have shown promising results in benign gynecological procedures.

Looking Ahead

The adoption of the Hugo RAS system represents a significant advancement in minimally invasive surgery, aligning with Medtronic’s mission to expand access to innovative surgical solutions worldwide. As various regulatory approvals are secured, including those necessary for urology indications, the potential for the Hugo system to transform surgical approaches continues to grow.

The continuing clinical use of the Hugo system across over 30 countries highlights its global impact. With nearly 300 independent publications highlighting its efficacy, the company is set to redefine the future of robotic-assisted surgery.

In summary, as Medtronic embarks on this crucial study, it aims not only to improve surgical outcomes but also to empower patients and healthcare providers with more effective and less invasive treatment options. For further information regarding the Hugo RAS system and ongoing clinical studies, visit Medtronic’s website at medtronic.com/hugo.