The US Food and Drug Administration (FDA) has granted 510(k) clearance for Nephros' hemodiafiltration (HDF) system, designed for the treatment of chronic kidney disease (CKD).
The hemodiafiltration system is used in conjugation with UF controlled dialysis machines capable of producing ultrapure dialysate to improve the quality of life for end-stage renal disease (ESRD) patients.
The HDF system features the company's OLpur MD220 hemodiafilter that employs proprietary mid-dilution hemodiafiltration technology and the OLpur H2H hemodiafiltration module, which is intended for use with UF controlled dialysis machines.
The HDF system removes a range of harmful substances effectively and with greater capacity than existing ESRD treatment methods, particularly with respect to substances known collectively as middle molecules, the company said.
Leonard Stern, Columbia University College of Physician and Surgeons medicine associate clinical professor and Columbia University Dialysis Center medical director, said HDF represents an alternative treatment option for chronic renal failure and patients in the US will now have the opportunity to be treated with the important therapy.
Nephros president and CEO, John Houghton, said the company can now offer 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. In parallel, Nephros will evaluate opportunities to leverage the resources of a strategic partner to most effectively address the market," Houghton added.
Nephros is a US-based medical device company focused on developing and marketing filtration products for therapeutic applications, infection control and water purification.
Image: The hemodiafiltration system from Nephros has been approved by the FDA. Photo courtesy of: FDA.