SeaStar Medicals Selective Cytopheretic Device Advancing Treatment for Acute Kidney Injury

 SeaStar Medical’s groundbreaking Selective Cytopheretic Device for Cardiorenal Syndrome has been granted an esteemed Breakthrough Device Designation by the FDA, acknowledging its immense potential in addressing the pressing clinical needs of acute kidney injury patients. This remarkable designation is anticipated to accelerate the device’s clinical development and regulatory review, paving the way for its utilization in this specific patient population.

Moreover, SeaStar Medical has taken a significant step forward by submitting an application for HDE (Humanitarian Device Exemption) approval from the FDA, with the intention of extending the benefits of their Selective Cytopheretic Device to children. However, it is important to note that the FDA has not yet granted approval for this HDE application, indicating that further evaluation and deliberation are required.

Furthermore, SeaStar Medical has achieved yet another milestone as they have successfully secured FDA approval to commence a groundbreaking study utilizing the Selective Cytopheretic Device. This study aims to mitigate hyperinflammation in adults suffering from acute kidney injury, a condition that poses significant challenges in the medical field. 

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