SeaStar Medical’s Selective Cytopheretic Device (SCD) [Image courtesy of SeaStar Medical]
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections.The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff said in an interview with Medical Design & Outsourcing.
The company is also planning a pivotal trial with around 200 adult AKI patients in early 2023, focused on reducing mortality and dialysis dependency.
SeaStar Medical CEO Eric Schlorff [Photo courtesy of SeaStar Medical]
SeaStar most recently studied the use of its Selective Cytopheretic Device (SCD) on 22…