The US Food and Drug Administration (FDA) has granted 510(k) approval to Nephros' Hemodiafiltration (HDF) system.
The approval of HDF system was based on the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate.
The HDF system includes the company’s dialyzer, OLpur MD220 Hemodiafilter, and OLpur H2H Hemodiafiltration module.
OLpur MD220 Hemodiafilter utilizes the company’s proprietary Mid-Dilution Hemodiafiltration technology and is designed for HDF therapy, while the module is designed for use with UF controlled dialysis machines capable of producing ultrapure dialysate.
Nephros president and CEO John Houghton said the company can now provide the only on-line HDF therapy available in the US.
"Nephros will first pursue a limited launch of its HDF system before expanding into the broader market," Houghton added.
"In parallel, Nephros will evaluate opportunities to leverage the resources of a strategic partner to most effectively address the market."