FDA Grants ExThera Medical’s Seraph 100 Blood Filter Expedited Access Pathway Designation
ExThera Medical Corporation has received FDA approval for the Seraph 100 Blood Filter for the agency’s Expedited Access Pathway designation.
The device will be an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is a heparin- or heparan sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE, and MRSE.
Seraph is different from other blood filters. The device removes many different pathogens simultaneously using a blood-contacting surface that does not injure the blood. It is designed to quickly treat blood stream infections to prevent them from becoming life-threatening.