On Thursday, Nephros, Inc. announced that they received 510k clearance from the U.S. Food and Drug Administration to market their MSU and SSU ultrafilters. These are to filter out biological contaminants from water and bicarbonate solution used in hemodialysis procedures.
Dr. Paul Mieyal, Acting Chief Executive Officer of Nephros, Inc., said, “Nephros is pleased to have received clearance from the FDA to market the MSU and SSU for hemodialysis applications. The MSU and SSU represent extensions of the Nephros ultrafiltration product line and enable Nephros products to address a wider range of fluid flow requirements.”
The Nephros DSU, MSU, and SSU are FDA cleared devices for the filtration of biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. To perform hemodialysis, ultrapure water is crucial to the production of dialysate. Dialysis clinics have water purification systems, but microbial contaminants can originate from the water treatment system, the water distribution loop, or the dialysate concentrates.
Nephros ultrafilters filter out substances down to the 0.005 micron level and address dialysate contamination at crucial points. These points are after the reverse osmosis module and at the dialysis machine entrance from the water distribution loop. Nephros ultrafilters can be used as the last step in the water purification process to ensure that ultrapure water is used for dialysis procedures.
Regular use of Nephros ultrafilters offers an affordable safety measure when used with modern water treatment systems and optimally maintained hemodialysis machines. Recent data have shown that the Nephros DSU (when used as part of the water purification system for dialysis systems) may reduce the required dosage of erythropoietin stimulating agents.
Headquartered in River Edge, New Jersey, Nephros, Inc. is a medical device company that lists on the OTC Bulletin Board. The Company is developing and marketing filtration products for therapeutic applications, infection control, and water purification.
The design of the Nephros hemodiafiltration (HDF) system is to improve the quality of life for the End-Stage Renal Disease (ESRD) patient while addressing the critical financial and clinical needs of the care provider. ESRD is a disease state characterized by the irreversible loss of kidney function. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods. This is specifically with respect to substances known collectively as “middle molecules.” These molecules have been found to contribute to such conditions as dialysis-related amyloidosis, carpal tunnel syndrome, degenerative bone disease and, ultimately, mortality in the ESRD patient.
The Nephros Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products. This includes the MSU and SSU ultrafilters. The patented dual stage cold sterilization ultrafilter can filter out bacteria. Because of its exceptional filtration levels, it can filter out many viruses, parasites and biotoxins. Nephros’ DSU ultrafilters are undergoing evaluation at several major U.S. medical centers for infection control. The U.S. Marine Corps has selected the Nephros ultrafilter technology for further development. This is for purification of drinking water by soldiers in the field.
For more information visit: www.nephros.com
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