Medtronic initiates U.S. IDE clinical study evaluating Hugo™ robotic-assisted surgery system for gynecological procedures

Core Insights - Medtronic has initiated the Embrace Gynecology clinical study to evaluate the safety and effectiveness of its Hugo robotic-assisted surgery system for gynecological procedures [1][2][3] Group 1: Study Details - The Embrace Gynecology study will enroll up to 70 patients across 5 U.S. hospitals, focusing on total hysterectomies, including those for malignancies [2] - The study aims to provide minimally invasive treatment options for women facing gynecological conditions, with robotic-assisted surgery expected to reduce complications and hospital stays [3][4] Group 2: Market Context - The National Cancer Institute projects that nearly 111,000 U.S. women will be diagnosed with gynecological cancer by the end of 2025, highlighting the need for effective surgical treatments [3] - The Hugo RAS system is already in clinical use in over 30 countries, with nearly 300 independent publications supporting its efficacy [6] Group 3: Company Commitment - Embrace Gynecology is the third IDE clinical study for the Hugo RAS system in the U.S., demonstrating Medtronic's commitment to expanding its indications [4] - The company has previously achieved primary safety and effectiveness endpoints in its other U.S. IDE studies, Expand URO and Enable Hernia Repair [4][5]