SeaStar Medical Holding (ICU) said Monday that the US Food and Drug Administration has approved its investigational device exemption application, allowing the conduct of a study to evaluate the safety and initial efficacy of its selective cytopheretic device, or SCD-Adult, in cardiorenal syndrome.
The device will be evaluated in adults with acute heart failure and worsening renal function or severe right ventricular failure awaiting left ventricular assist device implantation, according to SeaStar Medical.
The study is expected to include 20 patients at up to five clinical sites and is funded by a $3.6 million grant from the National Institutes of Health, SeaStar said.
Shares of the company were 3% lower in early trading Monday.
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