Denver-based SeaStar designed the SCD for use in patients in the intensive care unit (ICU) with acute or chronic systolic heart failure. These patients have worsening renal function due to cardiorenal syndrome or right ventricular dysfunction. They’re awaiting the implantation of a left ventricular assist device (LVAD).
SeaStar’s SCD halts the downward spiral perpetuated by a hyperinflammatory state, SeaStar chief medical officer Dr. Kevin Chung says.
The company said it expects the breakthrough nod to expedite the clinical development and regulatory review of the SCD.
SeaStar submitted a first-in-human study that saw a patient with severe chronic heart failure treated with the SCD. That patient was ineligible for heart transplantation or LVAD implantation. The patient achieved the primary endpoint of successful LVAD implantation and received a discharge to their home. SeaStar says the procedure also proved safe with no SCD-related serious adverse events.
“We believe the SCD represents a novel, innovative and transformative approach to treating hyperinflammation in severely ill patients with chronic heart failure,” said Eric Schlorff, SeaStar Medical CEO. “We plan to work in partnership with the University of Michigan to conduct a larger clinical study in the same patient population to gather additional evidence to support the submission of a premarket approval (PMA) application to the FDA.”
The SCD already had breakthrough designation for adults with acute kidney injury (AKI). SeaStar partnered with Nuwellis to market and distribute the SCD for that purpose last year.
