Shortly after granting an emergency authorization to Terumo BCT’s blood filtering device for COVID-19, the FDA did the same for CytoSorbents’ system. Both are designed to strip out the immune system proteins that fuel the deadly cytokine-storm reactions associated with the disease.
Previously cleared for use in the European Union, the company’s CytoSorb purification system has been used to treat septic shock patients receiving intensive care, as well as those undergoing heart surgery or experiencing liver failure.
Now with the FDA’s blessing, the filters can be used in U.S. intensive care units for adults suffering from imminent respiratory failure, with acute lung injuries or severe COVID-19 disease.
Cytokine storms can cause severe inflammation, tissue damage and rapidly progressive shock, following a cascading release of white blood cells as the body overreacts to the coronavirus infection.
CytoSorbents describes its filters as “plug-and-play compatible” with most blood purification devices or pumps found in the ICU, such as dialysis hardware or the lung-supporting extracorporeal membrane oxygenation hardware known as ECMO machines.
"As a U.S.-based company with CytoSorb device manufacturing in New Jersey, we are eager to expand the availability of CytoSorb to U.S. hospitals and patients as a treatment option to fight cytokine storm and deadly inflammation that is believed to exacerbate COVID-19 infection,” said CytoSorbents CEO Philip Chan.
“With more than 555,000 documented coronavirus infections, the U.S. leads the world with over 22,000 deaths, and emergently needs new therapies to reduce the severity of this disease,” Chan added, as of early April 13. “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."
CytoSorb has previously been used in more than 80,000 treatments overseas to help treat the same kinds of complications seen in COVID-19, he said, as well as more than 200 patients with the infection itself. Its use has also been included in treatment guidelines in Italy, Panama, and China.
“Under the EUA, we plan to ramp the availability of CytoSorb in a controlled manner, to clinical centers that will work with us to generate data and leverage our knowledge of how to use the device most effectively,” Chan said.