Medtronic plc (NYSE:MDT) Wednesday announced the commencement of the Embrace Gynecology investigational device exemption (IDE) U.S. clinical study to assess the safety and effectiveness of its Hugo robotic-assisted surgery (RAS) system in gynecological procedures.
This marks a significant step in the company’s strategy to expand its minimally invasive treatment options for patients in the U.S. market.
The initial procedures in the study, total hysterectomies, were successfully performed at AHN West Penn Hospital in Pittsburgh, Pennsylvania, by Dr. Sarah Crafton and Dr. Eirwen Miller, surgeons participating in the Embrace Gynaecology study at Allegheny Health Network.
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According to the National Cancer Institute, nearly 111,000 women in the U.S. are expected to be diagnosed with gynecological cancer by the end of 2025, while hundreds of thousands more will face benign conditions such as fibroids or abnormal uterine bleeding.
Embrace Gynecology is a prospective, multicenter clinical study designed to evaluate the safety and effectiveness of the Hugo RAS system in performing hysterectomy procedures including radical, modified radical, and total hysterectomies for malignant conditions. The study aims to enroll up to 70 patients across as many as five hospitals in the United States.
Dr. James Porter, chief medical officer of Robotic Surgical Technologies and Digital Technologies within the Surgical business of Medtronic, said, “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.”
Embrace Gynecology becomes the third IDE clinical study for Hugo RAS in the U.S., demonstrating Medtronic’s commitment to obtaining multiple indications for its Hugo RAS system. The two other U.S. IDE clinical 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 gynecologic procedures outside the U.S. were shared at the Society of Robotic Surgery congress in Strasbourg, France.
The company’s first U.S. submission, for a urology indication, is under review by the Food and Drug Administration and is expected later in the company’s current fiscal year, followed by planned indication expansions into hernia repair and gynecology.
The Medtronic Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo RAS system is CE marked. In the U.S., the Hugo RAS system is an investigational device not for sale.
Price Action: MDT shares were trading lower by 1.02% to $97.33 at last check Wednesday.
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