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# Breakthrough Designation for SeaStar Dialysis Device
- URL: https://www.fdaweb.com/breakthrough-designation-for-seastar-dialysis-device/
- Published: 2024-11-06T12:00:00.000Z
- Updated: 2026-09-14T14:46:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158136

FDA has granted a breakthrough device designation for SeaStar Medical’s Selective Cytopheretic Device (SCD) to treat chronic systemic inflammation in end-stage renal disease patients who require chronic hemodialysis. A company [statement](https://investors.seastarmedical.com/news/news-details/2024/FDA-Grants-Breakthrough-Device-Designation-for-SeaStar-Medicals-Selective-Cytopheretic-Device-for-Adults-Undergoing-Chronic-Dialysis/default.aspx?ref=fdaweb.com) says the SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy and reduces the hyperinflammatory milieu, including the cytokine storm. This is the fourth breakthrough designation for the SCD, SeaStar says.