Nipro Medical Corporation Introduces BPA- and DEHP-Free Dialyzer in U.S.

Nipro Medical Corporation has launched the next generation Elisio Polynephron Single Use, High-Flux, Hollow-Fiber Dialyzer, an improved version of the Elisio dialyzer launched early last year.

Both the housing and the membrane of the new dialyzer are made with material that does not contain BPA (Bisphenol A) or DEHP (Bis[2-ethylhexyl] phthalate). DEHP has been used as a plasticiser in medical devices such as intravenous tubing and bags, catheters, nasogastric tubes, dialysis bags and tubing, and blood bags and transfusion tubing, and air tubes. For this reason, concern has been expressed about leachates transported into the patient, especially for those requiring extensive infusions, e.g. newborns in intensive care nursery settings, hemophiliacs, and kidney dialysis patients. According to the European Commission Scientific Committee on Health and Environmental Risks, exposure to DEHP may exceed the tolerable daily intake in some specific population groups, namely people exposed through medical procedures such as kidney dialysis.

Elisio features a Polynephron membrane that functions similarly to a human kidney, delivering solute-removal performance, resulting in improved clearances for better patient outcomes, Nipro claims.

“We have taken a dialyzer that delivers excellent clearance and reduced thrombogenicity, and improved it by eliminating any BPA or DEHP,” said Joe Dawson, senior vice president, Nipro North America. “Both chemicals are known endocrine disruptors. There are many published studies showing that endocrine disruptors cause adverse effects in animals.”

The Elisio dialyzer’s advanced pore-spinning technology creates more homogenous pore sizes to optimize sieving properties and improve middle molecule clearance. In addition, the unique ripple structure in Elisio’s fiber creates less dialysate channeling – promoting better diffusive transport while enhancing small molecule clearances, and reducing the risk of fiber leakage, executives said in a news release.

The new polypropylene housing also is roughly 25 percent lighter than current dialyzers in the market, thus making disposal and transportation more cost effective. It also generates 25 percent less resin waste, and requires a lower temperature to mold polypropylene parts. In addition, polypropylene generates 10 percent fewer carbon dioxide emissions for resin production, and 50 percent fewer carbon dioxide emissions when incinerated.

“The eco-friendliness of the Elisio dialyzer is a definite plus,” Dawson said. “In addition, we do not have to compromise on clinical performance while making a greener dialyzer.”

The Elisio Polynephron Single Use, High-Flux, Hollow-Fiber Dialyzer is available in sizes from 0.9m² to 2.5m². Elisio has received 510(k) clearance from the U.S. Food and Drug Administration.

Nipro Medical is a manufacturer of renal and medical-surgical products. It is a wholly owned subsidiary of Nipro Corporation, headquartered in Osaka, Japan.