Blood Purification for the Treatment of Pathogen Associated Shock

Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) manufactured by ExThera Medical Corporation in Martinez, CA. The Seraph 100 filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin-coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins. The efficacy, safety, and risk-benefit data of the studies suggest that Seraph 100 is also safe and potentially beneficial by reducing the rate of thrombosis, without its use entailing a risk for patients. The achieved results from the above-mentioned testing and studies support the performance and safety of Seraph 100 consistent with the intended use. ExThera Medical concludes that the known and potential benefits of Seraph 100, when used to treat patients with pathogen associated shock, outweigh the known and potential risks when used according to the intended use.

"State of the Art careis defined as the treatment algorithms outlined in the Surviving Sepsis Campaign for the treatment of septic shock, available at https://www.sccm.org/SurvivingSepsisCampaign/Home"