Sedana Medical files submission for paediatric indication
Sedana Medical AB (publ) announces that the company has submitted a Type II variation with the aim of including the paediatric population (3-17 years) into the existing Sedaconda[®] indication for inhaled sedation of mechanically ventilated patients in Europe.The submission is based on the results of the IsoCOMFORT trial, a randomised active-controlled assessor-blinded study comparing the efficacy and safety of sedation with inhaled isoflurane, administered via the company’s medical device Sedaconda ACD-S, with intravenous midazolam in mechanically ventilated patients 3 to 17 years old.