SeaStar Medical Nabs Breakthrough Device Designation for Hepatorenal Syndrome

SeaStar Medical Holdings, a medtech company developing solutions to reduce the consequences of hyperinflammation on vital organs, recently announced it had obtained FDA Breakthrough Device Designation for its patented Selective Cytopheretic Device (SCD) for use in hepatorenal syndrome patients in the ICU. The hepatorenal syndrome designation becomes the company’s third for the SCD device, along with adult acute kidney injury (AKI) and cardiorenal syndrome.

Hepatorenal syndrome is characterized by abrupt deterioration of kidney function by a hyperinflammatory process in people with advanced liver cirrhosis. Without treatment, most patients die within weeks of the onset of renal failure. “Approximately 700,000 cases of hepatorenal syndrome are reported in the US annually,” according to the press release announcing the designation. “In 2019, the economic burden for hepatorenal syndrome hospitalization was estimated at $4.2 billion.”

SCD is a cell-directed extracorporeal therapy that works with most continuous kidney replacement therapy systems to selectively target the most highly activated neutrophils and monocytes — which play a key role in hyperinflammation — helping the body recover. “Based on our observations to date, the SCD may play a critical role in allowing the kidneys to recover such that these patients might become candidates for a life-saving liver transplant,” said Kevin Chung, MD, chief medical officer at SeaStar Medical, in the press release.

Some of these observations can be seen in the company’s investigator-initiated pilot study conducted at the University of Michigan. Assessing the SCD treatment of two patients with type 1 hepatorenal syndrome, the results were positive. The first patient with hepatorenal syndrome due to acute alcoholic hepatitis was shown to be alive at day 90 after seven days of SCD and was undergoing liver transplantation evaluation. The other patient, who had hepatorenal syndrome due to non-alcoholic steatohepatitis, had a successful liver transplantation six days after SCD therapy ended.

SeaStar Medical said that the study suggested “a role of SCD immunomodulation to treat acute on chronic liver failure, regardless of the etiology, as a bridge to evaluation or successful intervention for liver transplantation.”