FDA allows emergency use of blood purification technology used in cardiac surgery, critical care for COVID-19
CytoSorbents Corp. announced that its blood purification technology for the treatment of deadly inflammation and cytokine storm has been granted Emergency Use Authorization by the FDA for patients with COVID-19.
The technology (CytoSorb), typically used to treat patients who are critically ill or undergoing cardiac surgery, is currently approved in the European Union, according to a press release from the company. Through this Emergency Use Authorization (EUA), the company will make the technology available via commercial sales to all U.S. hospitals to treat patients 18 years and older with COVID-19 who are admitted to the ICU with imminent or confirmed respiratory failure. According to the release, the EUA applies to patients with acute respiratory distress syndrome or early acute lung injury; severe disease including dyspnea, high respiratory frequency or low blood oxygen saturation; or life-threatening illness including septic shock, respiratory failure and/or multiple organ failure or dysfunction.
“We greatly appreciate the FDA’s recognition, through this EUA, of the potential of CytoSorb and extracorporeal blood purification to help patients stricken with this terrible illness,” Vincent Capponi, chief operating officer of CytoSorbents, said in the release. “It was clear in this truly collaborative process with the FDA that the agency was committed to urgently providing physicians and patients with new treatment options in the fight against COVID-19. We plan to continue working with the FDA to help as many patients as possible.”
The technology aims to reduce the cytokine storm and severe inflammation similarly seen in patients with COVID-19 by way of blood purification to mitigate or prevent injury, according to the release. It can be used with most blood purification pumps or machines in the ICU including those for hemodialysis, hemoperfusion, extracorporeal membrane oxygenation and continuous renal replacement therapy.
“This is important not just to reduce poor clinical outcomes and mortality, but to also alleviate the bottleneck for scarce resources such as ventilators and ECMO in the treatment of these critically ill patients,” Phillip Chan, MD, PhD, CEO of CytoSorbents, said in the release.
The authorization does not permanently clear or approve the technology for use in patients with COVID-19, although it will be effective until the declaration is terminated, according to the release.
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Disclosures: Capponi and Chan are employees of CytoSorbents.