The D2000 – our distributor Marker Health’s patented plasma adsorption cartridge – reduces inflammatory cytokines, metabolic waste and toxins in the plasma during life-threatening conditions including ARDS, sepsis, liver failure, drug overdose, poisoning and other inflammatory responses. The disposable, easy-to-use device runs on existing hospital plasma separation platforms and is easily operable, requiring minimal clinician attention during therapy.
In early clinical trials, Marker Health has successfully used the device to treat patients suffering from ARDS, pneumonia, liver failure and sepsis. They continue to test its efficacy in treating a range of additional conditions. In their trials, there have been no adverse events and the application of the device has had excellent and measurably improved patient outcomes, potentially reducing the length and cost of patient stays in the intensive care unit (ICU).
Marker Health has conducted an IDE study in the US, trials at multiple international locations and recently received CE mark approval to make the device available in the EU and the UK. Their patents cover the device and pending improvements.
Marker Health has received an Emergency Use Authorization from the FDA for the use of the D2000 in multiple hospitals in the USA for the treatment of COVID-19 patients. Data will be collected under a protocol which will track patient outcomes to 28 days.
Please note that:
the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge have neither been cleared or approved for the indication to treat patients with COVID-19 infection;
the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge have been authorized by FDA under an EUA;
the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.