Medtronic (MDT) revealed that its Expand URO Investigational Device Exemption (IDE) clinical study, the most extensive of its kind for robotic-assisted urologic surgery, successfully met its primary safety and effectiveness goals. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo robotic-assisted surgery (RAS) system.
The rates of grade 3 or higher complications (3.7% prostatectomy, 1.9% nephrectomy, and 17.9% cystectomy) were favorably below the performance goals, which were established based on systematic review of published literature across all three cohorts.
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. There were two conversions: one was related to the device and one was related to patient anatomy.
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Business News
December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.