Nephros completes clinical trial for hemodiafiltration devices

NEW YORK—Nephros Inc. has completed a clinical trial for two hemodialfiltration devices, for which the medical-device company is looking to get regulatory approval.

Both of Nephros’ devices—the OLpur H2H module and OLpur MD220 filter—were developed to enable online hemodiafiltration with a conventional ultrafiltration-controlled hemodialysis machine, according to Nephros. Online HDF is a connective-based renal replacement therapy that is intended to improve the removal of uremic toxins.

Specific results were not released. Nephros said it is preparing to submit an approval application to the U.S. Food and Drug Administration.

"We're excited and pleased to have reached this important milestone,” Norman Barta, Nephros' CEO, said in a statement. “There is a broad range of literature supporting the advantages of hemodiafiltration over dialysis for the ESRD patient, including studies supporting a substantial reduction in the relative risk of mortality. While HDF is prevalent in Europe, no on-line HDF system has yet been approved for use in the U.S.  We believe our mid-dilution HDF technology can offer a vital advance in therapy to U.S. ESRD patients."