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Interest continues to grow in developing new strategies to reduce systemic inflammation as a means of improving outcomes in heart failure patients
DENVER, Feb. 27, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (NASDAQ:ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces publication of a manuscript discussing the role of chronic dysregulated systemic inflammation in heart failure and the potential application of the adult Selective Cytopheretic Device, part of the Quelimmune™ product family, in enabling previously ineligible patients with severe disease to receive a left ventricular assist device (LVAD) or heart transplant in the peer-reviewed European Journal of Heart Failure February 2024, Pitt, B., Iyer, S.P.N. and Humes, H.D. (2024), Eur J Heart Fail. https://doi.org/10.1002/ejhf.3177.
The manuscript, titled "New Opportunity for Targeting Systemic Inflammation in Patients with Heart Failure through Leukocyte Immunomodulation" cites increasing evidence of the role of chronic systemic inflammation in patients with heart failure and discusses the Adult SCD's potential to improve hypertensive heart failure and mortality following hospitalization for acute or worsening heart failure. The manuscript reviews the positive effect of the Adult SCD in a previously announced first-in-human case report of a 71-year-old patient with cardiorenal syndrome who was deemed ineligible for cardiac transplantation or a LVAD due to worsening renal function and right ventricular dysfunction. Following treatment with the Adult SCD, this patient was effectively bridged to LVAD three days after discontinuing treatment and was subsequently discharged without further complications. This study was the basis for Adult SCD receiving a Breakthrough Device Designation in cardiorenal syndrome from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) in September 2023.
"Systemic inflammation is one component in the multi-factorial pathophysiology of heart failure, and the use of anti-inflammatory strategies in patients with acute or worsening heart failure is not novel ," said lead manuscript author and heart failure expert Bertram Pitt, MD, FACC, Division of Internal Medicine (Emeritus), University of Michigan School of Medicine. "Prior attempts targeting singular proinflammatory factors as well as systemic immunosuppression with glucocorticoids in patients with acute heart failure have yielded unclear results, raising the need to identify new strategies. An alternative strategy may be to target cellular sources of proinflammatory molecules such as activated leucocytes."
"Our novel extracorporeal device has shown significant promise in targeting active neutrophils and monocytes to quell systematic inflammation, leading to improved outcomes in hyperinflammatory acute conditions including acute kidney injury, acute respiratory distress syndrome and cardiorenal syndrome," said manuscript co-author Sai Prasad N. Iyer, Ph.D., SeaStar Medical's Vice President, Medical Affairs and Clinical Development. "While our manuscript discusses a positive outcome in one patient following treatment for six hours daily over six consecutive days, the results suggest that more study with Adult SCD is warranted for patients with heart failure and hyperinflammation."
On February 22, 2024 SeaStar Medical announced the Humanitarian Device Exemption (HDE) FDA Approval Order for the Pediatric SCD (SCD-PED now known as Quelimmune) for use in children weighing 10 kilograms or more with acute kidney injury due to sepsis or a septic condition requiring kidney replacement therapy (KRT).
About Hyperinflammation
Hyperinflammation is the overproduction or overactivity of inflammatory cells that can lead to damage of vital organs. It occurs when the body overproduces inflammatory effector cells and other molecules that can be toxic, damaging to vital organs and result in multi-organ failure and even death. This is known as the cytokine storm.
About the Selective Cytopheretic Device (SCD)
The SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm that causes inflammation, organ failure and possible death in critically ill patients. Unlike pathogen removal and other blood-purification tools, the device is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. The SCD selectively targets the most highly activated proinflammatory neutrophils and monocytes. These cells are then returned back into the body through the blood, and the body is signaled to lower its inflammatory environment and focus on repair. This unique immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis.
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