Sedana Medical Receives Fast Track Designation from the US FDA to Isoflurane Administered via Sedaconda ACD-S Device for Sedation
Shots:
- The FTD has been granted for the combination of Sedaconda (isoflurane) administered via Sedaconda ACD (device) for the sedation of ventilated patients in the ICU
- The designation follows the data from two P-III studies (INSPiRE-ICU 1 & 2), evaluating the efficacy and safety of inhaled isoflurane, delivered via the Sedaconda ACD vs. propofol (IV) across the US (25-30 sites) in 470 patients & expects to be completed the NDA submission in 2024
- The 1EP is the proportion of time spent within the target range of sedation depth in absence of rescue sedation, as assessed acc. to the RASS & 2EPs incl. the use of opioids, the wake-up time, the cognitive recovery after end of sedation, and the spontaneous breathing effort
Ref: PRNewswire | Image: Sedana Medical
Related News:- Acacia Pharma's Byfavo (remimazolam) Receives the US FDA's Approval for the Induction and Maintenance of Procedural Sedation
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
