Medtronic announces Expand URO IDE study met primary safety, effective endpoint

Medtronic (MDT) 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 Huge robotic-assisted surgery, RAS, system. The data, described by the American Urologic Association as a “practice-changing, paradigm-shifting clinical trial in urology”, was presented today at the AUA annual meeting in Las Vegas by Michael R. Abern, M.D., the study’s national principal investigator and a urologic surgeon at Duke University Hospital in Durham, N.C. Expand URO study primary endpoint data: Safety: The rates of grade 3 or higher complications were favorably below the performance goals, which were established based on systematic review of published literature across all three cohorts. Effectiveness: The study’s 98.5% surgical success rate was well above the performance goal of 85%, which was established based on a systematic review of published literature. There were two conversions: one was related to the device and one was related to patient anatomy.