Frequently Asked Questions
Learn More About Seraph 100 and ExThera Medical
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
What is the Seraph?
How does the Seraph 100 work?
As blood flows through the Seraph filter, it passes over microbeads 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 bind to the Seraph beads and are removed from the bloodstream.
Are there any known side effects or potential dangers?
How do I use the Seraph 100 to treat COVID-19?
Seraph 100 is compatible with standard hemodialysis circuits and connectors. Refer to the product Instructions for Use (IFU) for greater detail.1
When should I start treatment with the Seraph 100?
Seraph 100 is indicated 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 100.1
What should I do if I have a complaint about a product?
If you have any concerns or complaints about our products, please email [email protected] with details about the issue, including the product name, batch/lot number, and a brief description of the problem. We aim to respond to all product feedback and complaints within two business days.
1. | Seraph 100 Microbind Affinity Blood Filter Instructions For Use: CP021 Rev A FDA EUA200165 |
MM-00022 Rev F