Medical device company SeaStar Medical Holding Corporation (Nasdaq:ICU) announced on Friday that it has secured Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its cell-directed Selective Cytopheretic Device (SCD).

The SCD targets patients in the intensive care unit (ICU) with acute or chronic systolic heart failure and deteriorating renal function due to cardiorenal syndrome or right ventricular dysfunction while awaiting left ventricular assist device (LVAD) implantation.

Breakthrough Device Designation is anticipated to expedite the clinical development and regulatory review of the SCD for use in this patient population. This represents only the ninth Breakthrough Device Designation granted by the FDA's Center for Biologics Evaluation and Research (CBER) since the program's inception in 2015.

"Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis," explained Kevin Chung, MD, chief medical officer of SeaStar Medical. "The SCD is able to halt the downward spiral often perpetuated by a hyperinflammatory state driven by the innate immune system, giving these patients a fighting chance."