FDA Confirms SeaStar Medical Has Fulfilled the Post-Approval Study Requirements for QUELIMMUNE® for the Treatment of Sepsis-Associated Acute Kidney Injury (AKI) in Pediatric Patients
The FDA's CBER confirmed that SeaStar Medical's QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled the post-approval study requirements from the original Humanitarian Device Exemption approval. SAVE Registry data presented at ASN Kidney Week 2026 showed statistically significant improved 90-day survival of 65.1% for QUELIMMUNE patients versus 47.5% in clinically aligned comparison cohorts (P = 0.043), with no device-related adverse events.
Key figures
- Drug Name
- QUELIMMUNE (SCD-PED)
- P value
- 0.043
- Control n
- 196
- Treated n
- 43
- Survival 90d control
- 47.5%
- Survival 90d treated
- 65.1%
- Device related adverse events
- 0
AI analysis
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