SeaStar Medical’s Device to Treat Inflammation in ESRD Receives FDA Breakthrough Designation

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to SeaStar Medical Holding Corporation’s Selective Cytopheretic Device (SCD). The device is used to treat chronic systemic inflammation in patients with end-stage renal disease (ESRD) who require chronic hemodialysis.

More than 480,000 people with ESRD are treated with in-center hemodialysis at least three times a week in the US. According to Kevin Chung, MD, chief medical officer of SeaStar Medical, patients with ESRD face chronic fatigue, malnutrition, repeat hospitalizations, and a 42% five-year survival; systemic inflammation is a driver of those outcomes.

“Initial data shows that the SCD has the potential to address chronic systemic inflammation in a safe and effective manner that could improve survival, quality of life and other relevant clinical outcomes,” Dr. Chung said in a press release.

The SCD uses immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during continuous renal replacement therapy (CRRT) and reduces the hyperinflammatory milieu including cytokine storm. The SCD is integrated with CRRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This approach may promote long-term organ recovery and eliminate the need for future RRT, including dialysis.

The SCD has received FDA Breakthrough Therapy Designation for four indications: chronic dialysis, adult acute kidney injury, hepatorenal syndrome, and cardiorenal syndrome – left ventricular assist device.

Source: Press release