US-based Nipro Medical has announced the launch of its Elisio Polynephron dialyser, designed for the renal market, targeting those involved in care and procedures for kidney disease and dialysis.
The Elisio dialyser is equipped with a new high-flux membrane, Polynephron. According to Nipro Medical, the Polynephron membrane functions similarly to a human kidney and delivers biocompatibility, haemocompatibility, and solute-removal performance.
A 3D chemical structure enables a mixture of hydrophilic and hydrophobic domains, while reducing membrane fouling and maximising membrane performance.
Advanced pore-spinning technology of the new dialysis device creates more homogenous pore sizes to optimise sieving properties.
Ripple structure of Elisio's fibre creates less dialysate channelling, promoting improved diffusive transportation while enhancing small molecule clearances, and reducing the risk of fibre leakage.
The inner design of the Elisio dialyser offers a smooth polyurethane cut surface, which helps minimise the risk of blood cell damage.
An improved header shape reduces channelling at the blood side, and the redesigned permanent caps eliminate the possibility of unexpected removal or reuse.
Nipro North America senior vice-president Joe Dawson said: "The introduction of the Elisio dialyser builds on our strategy of becoming a complete and cost-effective dialysis solutions leader, offering blood tubing lines, fistulas needles, and now dialysers to our dialysis market partners in the US market. Elisio is designed to deliver an elevated benefits platform to the market, especially in clearance performance of small to middle molecules, and it delivers on these objectives.
"Both in-vitro and in-vivo testing have demonstrated the superior clearance performance of the Elisio dialyser for both small and middle molecules. In addition, clinicians reported excellent performance with regard to myglobin and B2 microglobulin, and excellent biocompatibility on WBC and C5a.
Nipro Medical has already obtained 510(k) approval from the US Food and Drug Administration for the Elisio Polynephron dialyser.
The single use, high-flux, hollow-fibre dialyser is now available in sizes from 90H to 250H.