Safety of in | 合法醫療器材資訊網

由PSanders著作·2019·被引用1次—Atotalof191patients(45.5%femaleaged63.8±26.9years)underwentsuccessfulRevealLINQICMinsertionat17centersinEurope,Canada ...

The RIO2 International study evaluated the safety of performing Reveal LINQ ICM insertions in-hospital, but outside the traditional procedure settings. It is the first study to characterize resource utilization, procedure time intervals, and physician satisfaction from multiple centers across different geographies, including Europe, Canada and Australia. All 191 insertion attempts were successful, and no untoward events were observed among the 176 patients evaluable for the primary endpoint during a follow-up period of 3 months. Additionally, there was high compliance with the protocol specified insertion procedure. Importantly, even under circumstances with deviations from protocol, there was no increase in the risk of adverse events, punctuating the benign nature of the insertion procedure. As such, these results provide strong evidence that the Reveal LINQ ICM insertion can be safely performed out-of-lab within t...