The US Food and Drug Administration (FDA) has granted breakthrough device designation to SeaStar’s selective cytopheretic device (SCD), meaning the agency will fast-track the product’s route to market for heart failure patients in hospital intensive care units.
SeaStar’s device is used to treat hyperinflammation in patients with chronic heart failure. SCD selectively targets overproduced inflammatory effector cells, including neutrophils and monocytes, and neutralises them. Normally, the overactivity of the immune system can lead to organ damage and can even lead to multi-organ failure.
The device is indicated for patients in intensive care with acute or chronic systolic heart failure, and who also have worsening renal function caused either by cardiorenal syndrome or right ventricular dysfunction.
SeaStar Medical’s chief medical officer Dr Kevin Chung said: “Cardiorenal syndrome is seen in the most severe cases of heart failure and is associated with a very poor prognosis. 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.”
SeaStar Medical submitted preclinical data to the FDA in addition to a first-in-human study – funded by the National Institutes of Health (NIH) – which met its primary endpoint.
SeaStar Medical CEO Eric Schlorff said: “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.”
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In January 2023, SeaStar Medical entered into a US licence and distribution agreement with Nuwellis for SCD in acute kidney injury (AKI). The company is currently investigating the device in combination with continuous kidney replacement therapy (CKRT) in critically ill patients with AKI.