Sedana Medical Gains Fast Track Nod to Evaluate Use of Isoflurane with Device in the ICU

The FDA has granted Sedana Medical a Fast Track designation to evaluate isoflurane with its Sedaconda ACD-S device to sedate mechanically ventilated patients in intensive care.

The combination drug-device is currently being compared to intravenous propofol in two phase 3 studies. The primary endpoint is the proportion of time spent within the target range of sedation depth in absence of rescue sedation.

In addition to administering the volatile anesthetic, the Sedaconda ACD-S acts as a heat and moisture exchanger, and includes an electrostatic filter for bacteria and viruses.

The company expects to submit a New Drug Application for the combination drug-device in 2024.