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Frequently Asked Questions

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What is the Seraph?

The Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single-use broad-spectrum extracorporeal hemoperfusion device for use as an adjunctive treatment for COVID-19 infection.1 It is designed to treat bloodstream infections by binding pathogens from the blood, including SARS-CoV-2 (COVID-19).2,3 Learn more

What is the Seraph?

The Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a single-use broad-spectrum extracorporeal hemoperfusion device for use as an adjunctive treatment for COVID-19 infection.1 It is designed to treat bloodstream infections by binding pathogens from the blood, including SARS-CoV-2 (COVID-19).2,3 Learn more

How does the Seraph 100 work?

As blood flows through the Seraph filter, it passes over proprietary beads coated with molecular heparin receptor sites that mimic the heparan sulfate receptors on human cells that pathogens attack when invading the body. These harmful pathogens, which include bacteria, viruses, fungi, and other disease-causing molecules, bind to the Seraph beads and are removed from the bloodstream without negatively impacting the blood cells or proteins.3 

Are there any known side effects or potential dangers?

Possible Seraph 100 side effects include those seen in patients undergoing other extracorporeal treatments like dialysis; however, no serious adverse events or treatment-related side effects have been reported with the Seraph 100 since commercial use began from August 2019 through February 2021, when this section was last updated.4 This is likely due to the biomimetic nature of the device and the adsorption process, which mimics the chemistry and molecular structure of the surface of healthy blood vessels.3

How is the Seraph different from other blood filters?

Some other blood filters remove inflammatory mediators, but do not address the source of the disease. Preclinical and clinical studies demonstrate that Seraph can efficiently remove pathogens while also reducing the concentration of inflammatory mediators and other substances that contribute to the severity of COVID-19.3 

How does blood filtering help treat COVID-19?

COVID-19 is not just a disease of the respiratory system. Peer-reviewed literature confirms that SARS-CoV-2 enters the bloodstream during moderate to severe COVID-19 infections.5,6,7 Viral RNA, the genetic material of the virus, can be found throughout the body in kidney cells, in heart cells, and in the blood vessels themselves that circulate the body through the bloodstream. Several publications have demonstrated a correlation between disease severity and the amount of virus that is in the blood.5,6,7 It is likely that by binding COVID-19 and resultant inflammatory mediators, Seraph 100 may improve patient outcomes. Seraph 100 is CE marked and commercially available in Europe and available in the US through Emergency Use Authorization (EUA) granted by the FDA for the treatment of COVID-19.8,9

“Cytokine storms” appear in severe COVID-19 cases. Can the Seraph help prevent these?

The cytokine storm is known to occur in some severe COVID-19 patients. However, publications have reported that cytokine levels are significantly lower in most severe COVID-19 patients with acute respiratory distress syndrome (ARDS) as compared to patients with septic shock, both with and without ARDS.5,10 Data has shown that SARS-CoV-2 viremia is associated with elevated cytokines.7 The Seraph 100 may help prevent the cytokine storm by binding the virus before the storm occurs. Additional data indicates that inflammatory mediators such as IL-6, ferritin, and D-dimer have dropped either during or shortly after treatment with Seraph 100.11

How do I use the Seraph 100 to treat COVID-19?

The device has standard luer fittings and a low pressure drop making it compatible with most blood pumps and dialysis equipment.4 Patients can be treated with the filter using flow rates between 100 and 350 mL/min.1 Patients should be systemically anticoagulated prior to treatment.1 Clinicians have observed the best results when patients are treated prior to or soon after needing intubation/mechanical ventilation, as rapidly reducing the viral load may prevent the cytokine storm and severe clotting issues that are typical for ICU patients.12 Refer to the product Instructions for Use (IFU) for greater detail.1 

When should I start treatment with the Seraph 100?

The Seraph 100 is usually reserved for the severe or critically ill patient per the following indications for use (IFU):1

Seraph 100 is reserved for patients with laboratory-confirmed and symptomatic COVID-19 with any of the following: 

      • Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)

      • Severe disease, defined as: 
        • Dyspnea 
        • Respiratory frequency ≥ 30 breaths/min 
        • Blood oxygen saturation ≤ 93%, 
        • Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or 
        • Lung infiltrate >50% within 24 to 48 hours 
      • Life-threatening disease, defined as: 
        • Respiratory failure 
        • Septic shock, and/or 
        • Multiple organ dysfunction or failure 

Please consult the instructions for use in entirety for complete information of safety and appropriate use of the Seraph 100.

What evidence is there to demonstrate the effectiveness of Seraph 100?

In Europe, a human clinical trial determined the safety and performance of the device in use, necessary for CE mark.8 Clinical studies are underway in the United States.13 Anecdotal observations of the Seraph 100 include improving patient outcomes, reducing lengths of stay, and helping some patients avoid intubation.12 Independent studies have demonstrated the science behind the Seraph 100, including those in the Journal of Microbiology and Biotechnology, the American Society of Artificial Internal Organs Journal, and Critical Care Explorations, among others. 2,3,14-20

Are there registries/studies where I can participate in the EU?

Several clinical trials are underway and can be viewed on the Clinical Trials page.

[sources]

  1. Seraph 100 Microbind Affinity Blood Filter Instructions For Use: CP021 Rev A FDA EUA200165
  2. Olson et al, Treatment for Severe Coronavirus Disease 2019 With the Seraph-100 Microbind Affinity Blood Filter, Critical Care Explorations, (2020), 2(8),1-6
  3. Seffer et al, Heparin 2.0: A New Approach to the Infection Crisis, Bld Purification (2020); Jul 2, 1-7
  4. Data on file, Exthera Medical Corporation
  5. Fajnzylber et al, SARS-CoV-2 viral load is associated with increased disease severity and mortality, Nature Communications; 2020, (11);5493
  6. Bermejo-Martin et al, SARS-CoV-2 RNA viremia is associated with a sepsis-like host response and critical illness in COVID-19; Crit Care, 2020, 24;691
  7. Chen et al, Detectable 2019-nCoV viral RNA in blood is a strong indicator for the further clinical severity, Em Mic and Inf; 2020, 9;469-473
  8. EU CE Mark approval: Ref 0459
  9. https://www.fda.gov/media/137101/download
  10. Kox et al, Cytokine Levels in Critically Ill Patients With COVID-19 and Other Conditions. JAMA. 2020;324(15):1565–1567
  11. Sandoval et al, Treatment for Severe Coronavirus Disease 2019 with a biomimetic sorbent hemoperfusion device in patients on hemodialysis, Clinical Kidney Journal, 2021; sfab010
  12. Preliminary compiled data to be published
  13. https://www.clinicaltrials.gov/ct2/results?recrs=&cond=&term=seraph+100&cntry=&state=&city=&dist= 
  14. Seffer et al, Elimination of Staphylococcus aureus from the bloodstream using a novel biomimetic sorbent haemop…, BMJ Case Studies (2020); 13(8)
  15. Schmidt et al, In vitro elimination of anti-infective drugs by the Seraph® 100 Microbind® affinity blood filter, CKJ (2020); 13(3), 421-424
  16. McCrea et al, An affinity adsorption media that mimics heparan sulfate proteoglycans for the treatment of drug-resistant…, Sur Sci (2016); 648, 42-46
  17. McCrea et al, Removal of Carbapenem-Resistant Enterobacteriaceae (CRE) from Blood by Heparin-Functional Hemoperf, PLOS One (2014); 9(12)
  18. LaRosa et al, Immune Aspects of Sepsis and Hope for New Therapeutics, Curr Infect Dis Rep (2012); 14, 474-483
  19. Mattsby-Baltzer et al, Affinity Apheresis for Treatment of Bacteremia Caused by Staphylococcus aureus and/or Methiciliin-Resistant S… (2011); 21(6), 659-664
  20. Axelson et al, Cytokines in Blood from Septic Patients Interact With Surface-Immobilized Heparin, Clin Cardio (2010); 56(1), 48-51

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DISCLAIMERS
*The Seraph® 100 Microbind® Affinity Blood Filter (Seraph) is CE Marked and approved for commercial sale in EU member states.
**Emergency Use Authorization Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is for use in the United States under FDA EUA200165:
Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.
The Seraph 100 device has neither been cleared or approved for the indication to treat patients with COVID-19 infection.
The Seraph 100 device has been authorized by FDA under an Emergency Use Authorization (EUA).
The Seraph 100 device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph device 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.