SCD (Pediatric)
Systemic Inflammatory Response in Cardiac Surgery (Pediatric)
InvestigationalBreakthrough Device Designation awarded
Key Facts
Indication
Systemic Inflammatory Response in Cardiac Surgery (Pediatric)
Phase
Investigational
Status
Breakthrough Device Designation awarded
Company
About SeaStar Medical
SeaStar Medical is on a mission to save lives by calming the cytokine storm, a destructive hyperinflammatory response that leads to organ failure in critically ill patients. The company has achieved its first FDA approval under a Humanitarian Device Exemption for its lead product, Quelimmune, to treat pediatric acute kidney injury, and has launched it commercially. With a robust pipeline backed by multiple FDA Breakthrough Device Designations, SeaStar is advancing its Selective Cytopheretic Device (SCD) technology into pivotal and feasibility studies for adult acute kidney injury, cardiorenal syndrome, and other severe inflammatory conditions.
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