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Clinical Safety and Efficacy Testing of the First Indian Hemodialysis Device

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Dr Shetty MS, Dr Kiran KK, Mysore; Dr Sharma A, Bengaluru    28 December 2018

Dr Shetty MS, Dr Kiran KK, Mysore; Dr Sharma A, Bengaluru; Dr Keshaviah P, Dehradun; Dr Rao SV, Dr Vincent L, Bengaluru

This open label, single group, controlled, crossover study involving 5 patients assessed the safety and efficiency of an Indian hemodialysis device (Renalyx RxT17). The hemodialysis machine was found to be noninferior to a standard of care machine (Fresenius 4008S). No significant difference was found in the efficacy and safety of delivering normal dialysis to patients with ESRD in the exploratory clinical trial.

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