Medtronic announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints.
The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.
The data, described by the American Urologic Association (AUA) as a "practice-changing, paradigm-shifting (P2) clinical trial in urology", was presented at the AUA annual meeting.
The study's 98.5% surgical success rate was well above the performance goal of 85% (p<0.0001), which was established based on a systematic review of published literature.
The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology.
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