NIPRO CORPORATION introducing HDs to the United States following FDA clearance
NIPRO CORPORATION has been granted 510(k) clearance for the ELISIO-HX dialyzer by the U.S. Food and Drug Administration (FDA), enabling the introduction of hemodialysis powered by super high-flux membrane (HDs) in the United States.
HDs are NIPRO's approach within expanded hemodialysis (expanded HD), providing healthcare professionals with a pathway to enhance hemodialysis while using existing dialysis infrastructure and established clinical workflows.
Expanded HD is designed to extend the removal of larger middle molecules beyond conventional high-flux dialysis. HDs combine the ELISIO-HX dialyzer with NIPRO's proprietary membrane technology, enabling enhanced middle molecule removal while remaining fully compatible with routine hemodialysis practice.
Hemodialysis remains the cornerstone of treatment for patients with end-stage kidney disease in the United States. Although treatment standards continue to evolve, there remains an ongoing need to improve the removal of a broader range of uremic toxins, including larger middle molecules that have been associated with chronic complications of kidney disease.
ELISIO-HX has been developed to address this need through an approach designed for broad patient eligibility and straightforward integration into routine dialysis care.
With the 510(k) clearance, NIPRO will begin the commercialization of ELISIO-HX in the United States immediately. NIPRO will work closely with healthcare providers to support the successful introduction of HDs into routine clinical practice.
