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Nephrology Times

Nephrology Times delivers the latest news in kidney-related treatments and technologies with the goal of better informing care decisions and improving patient outcomes.

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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. ...
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