SeaStar Medical says FDA approves feasibility study with SCD-ADULT

SeaStar Medical (ICU) announced that the U.S. FDA has approved an investigational device exemption application to evaluate the safety and initial efficacy of SeaStar Medical’s Selective Cytopheretic Device, or SCD-ADULT, in reducing inflammation in adult patients with acute heart failure with worsening renal function due to cardiorenal syndrome or severe right ventricular failure awaiting a left ventricular assist device implantation. This feasibility study is expected to enroll 20 patients at up to five clinical sites and will be funded by a previously announced $3.6M National Institutes of Health grant awarded to Innovative BioTherapies, which is led by SCD inventor H. David Humes, MD, Professor, Division of Nephrology, Internal Medicine, University of Michigan and SeaStar Medical Scientific Advisor. Dr. Humes will serve as lead investigator for the study and SeaStar Medical will act as clinical research organization. The FDA’s Center for Biologics Evaluation and Research granted Breakthrough Device Designation for the SCD in cardiorenal syndrome with LVAD in September 2023.