- Medtronic's Expand URO clinical trial successfully met primary safety and effectiveness endpoints.
- The trial, involving 137 patients, is the largest multi-center prospective IDE study for robotic-assisted urologic surgery in the U.S.
- Hugo robotic-assisted surgery system has been submitted to the FDA for regulatory review.
Medtronic (MDT, Financial), a leader in healthcare technology, recently announced the successful outcomes of its Expand URO Investigational Device Exemption (IDE) clinical study. This trial, the largest of its kind for robotic-assisted urologic surgery in the United States, has met both the primary safety and effectiveness endpoints. Conducted with 137 patients, the study utilized the Hugo™ robotic-assisted surgery (RAS) system, receiving high praise as a "practice-changing, paradigm-shifting" trial by the American Urologic Association (AUA).
Presented at the AUA annual meeting in Las Vegas by Dr. Michael R. Abern from Duke University Hospital, the study demonstrated a surgical success rate of 98.5%, surpassing the performance goal of 85% which was derived from a systematic review of published literature. Safety outcomes were also favorable, with complication rates significantly below established performance goals for prostatectomy, nephrectomy, and cystectomy procedures.
The successful completion of this trial has paved the way for Medtronic to submit the Hugo RAS system to the U.S. Food and Drug Administration (FDA) for regulatory approval. This submission marks a crucial step toward Medtronic's entry into the U.S. robotic surgery market, further expanding its reach with the Hugo RAS system already in clinical use across more than 25 countries.
The Hugo RAS system is designed to offer a modular and flexible approach to minimally invasive surgeries, supporting seamless communication amongst surgical teams and providing a smart, connected surgical experience. Medtronic's commitment to innovation in robotic surgical technologies underscores its mission to expand access to advanced medical solutions worldwide.
