FDA Clearance For Nephros Hemodiafiltration System

“HDF represents an alternative treatment option for chronic renal failure, and I am excited that patients in the United States will now have the opportunity to be treated with this important therapy”

In short

Filtration device specialist Nephros, Inc., has announced FDA 510(k) clearance to market its Hemodiafiltration (“HDF”) system for the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate.

Background 

26 million American adults have Chronic Kidney Disease (CKD) and millions of others are at increased risk. CKD is a progressive disease which ultimately leads to kidney failure. There are more than half a million patients whose kidneys have failed requiring them to seek treatment. Of this, approximately 370,000 are receiving hemodialysis and this number is growing year on year. In 2009 the total medical care costs for Chronic Renal Failure reached $42.5 billion.

The newly cleared system comprises Nephros’s OLpur MD220 Hemodiafilter and Nephros’s OLpur H2H Hemodiafiltration module. The Hemodiafilter is a dialyser designed expressly for HDF therapy that employs Nephros’s proprietary Mid-Dilution Hemodiafiltration technology. The Hemodiafiltration module is intended for use with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards.

Clinician comments

“HDF represents an alternative treatment option for chronic renal failure, and I am excited that patients in the United States will now have the opportunity to be treated with this important therapy,” said Leonard Stern, M.D., Medical Director at Columbia University Dialysis Center, and Associate Clinical Professor of Medicine, Columbia University, College of Physician and Surgeons.

Company comments 

“Nephros can now offer the only on-line HDF therapy available in the U.S.,” said John C. Houghton, President & CEO of Nephros, Inc. “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.”

Source: Nephros Inc., PR Newswire