COVID-19: FDA Approves Terumo’Spectra Optia ‘: Decreases Plasma / Cytokines

COVID-19: FDA Approves Terumo’Spectra Optia ‘: Decreases Plasma / Cytokines

COVID-19:

April 13, 2020

April 9th,

Terumo: Centrifugal blood component separator

“Spectra Optia” has received Emergency Use Authorization (EUA) for COVID-19 patients from the US Food and Drug Administration (FDA).

Marker Therapeutics AG: (Zug, Switzerland)

Used in combination with the “D2000 adsorption cartridge” in the intensive care unit (ICU) for COVID-19 / patients with respiratory failure.

Detailed information will be announced once the content of the announcement in Japanese is finalized.

Press Release | Terumo

https://www.terumo.co.jp/pressrelease/detail/20200413/1073/index.html

New Corona / Terumo Blood Component Separator / U.S.A.

Spectra Optia:

It is used sequentially in the United States, which has the highest number of infected people

Separates blood into blood cells and plasma by passing the patient’s blood through a dedicated disposable circuit.
An adsorption cartridge connected to the circuit reduces the cytokines present in the plasma and the blood returns to the patient’s body.
Due to the decrease in cytokine, cytokine storm is suppressed, and improvement of respiratory disorder can be expected.
The combination of Spectra Optia and adsorption cartridges is licensed only during periods of public health emergency.

As the new corona infection spreads, attention will be focused on the success of products that are used sequentially in the United States, which has the highest number of people infected.

Chemical Daily

https://www.chemicaldaily.co.jp/

Terumo BCT and Marker Therapeutics Received the First Device FDA Emergency Use Authorization (EUA) to Treat Acute Respiratory Failure in COVID-19 Patients | Newsroom | Terumo Global

https://www.terumo.com/pressrelease/detail/20200410/525/index.html?_ga=2.46698407.1441995218.1587271955-612294237.1585996329

Coronavirus (COVID-19) Update:

FDA Authorizes Blood Purification Device to Treat COVID-19

For Immediate Release:

April 10, 2020

The U.S. Food and Drug Administration

issued an emergency use authorization for a blood purification system to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The authorized product

works by reducing the amount of cytokines and other inflammatory mediators, i.e., small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient.

The proteins that are removed are typically elevated during infections and

can be associated with a “cytokine storm” that occurs in some COVID-19 patients, leading to severe inflammation, rapid progressive shock, respiratory failure, organ failure and death.

FDA

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-blood-purification-device-treat-covid-19