“We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies,” said FDA Commissioner Stephen M. Hahn, M.D. “With today’s authorization of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease. Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”
The company’s CytoSorb purification system was previously cleared for use in the European Union to treat septic shock patients receiving intensive care as well as those undergoing heart surgery or those experiencing liver failure.
The FDA emergency authorization allows the filters to be used in American intensive care units for adults suffering from imminent respiratory failure with acute lung injuries or severe infection with COVID-19 disease.
As the body overreacts to the COVID-19 infection a cascading release of white blood cells creates a cytokine storm that can cause severe inflammation, tissue damage and rapidly progressive shock. These systems should help to filter out the proteins fueling the cytokine storm and help to save lives.
The company describes these filters as being plug and play compatible with most blood purification devices or pumps that can be found within an ICU such as dialysis or the lung supporting extracorporeal membrane oxygenation hardware 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.”
This system, according to the company, has been used in over 80,000 treatments overseas to assist with similar kinds of complications that are being seen in COVID-19, as well as with over 200 patients with this infection, and it is included in treatment guidelines in China, Italy, and Panama.
“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.
