SeaStar Medical's QUELIMMUNE shows 65.1% 90-day survival in pediatric AKI study
ICU•SeaStar Medical said its QUELIMMUNE therapy showed 65.1% 90-day survival in a pediatric acute kidney injury study and fulfilled FDA post-approval study requirements.
1. Study requirements fulfilled
SeaStar Medical’s QUELIMMUNE fulfilled FDA post-approval study requirements for treating sepsis-associated acute kidney injury in pediatric patients. Hospitals can now use the therapy without the SAVE Registry’s research infrastructure.
2. Registry results
SAVE Registry results showed significantly improved survival compared with clinically aligned pediatric database cohorts. No device-related adverse events were reported among registry patients.
