Health Canada Approves Nephros’ Hemodiafilter for Marketing

Nephros has received approval from Health Canada’s Therapeutic Products Directorate to market its OLpur MD hemodiafilter series in Canada.

The series received CE Marking in 2003 and is in use in more than 50 European clinics. The OLpur H2H hemodiafiltration (HDF) module is designed to convert the most common types of hemodialysis machines to HDF therapy.

Nephros plans to seek FDA approval to market the OLpur H2H module and its hemodiafilter, following completion of a pivotal U.S. clinical trial for the products. The company said that, when approved, its mid-dilution HDF technology would be the first approved online HDF therapy in the U.S.