Nipro Corporation has been granted 510(k) clearance for the Elisio-HX dialyser by the United States Food and Drug Administration (FDA).
The clearance enables the introduction of HDs (haemodialysis powered by super high-flux membrane) in the United States.
HDs is Nipro’s approach within expanded haemodialysis (Expanded HD), providing healthcare professionals with a practical way to enhance haemodialysis while using existing dialysis infrastructure and established clinical workflows.
Haemodialysis 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.
At the core of HDs is the Elisio-HX dialyser, featuring Nipro’s proprietary super high-flux membrane technology.
The membrane incorporates a highly controlled and precisely engineered pore structure that extends the removal profile of larger middle molecules while maintaining albumin retention, an important consideration in preserving patients’ nutritional status.
This precision-engineered membrane design enables healthcare professionals to enhance dialysis treatment while remaining fully compatible with conventional haemodialysis systems.
Because Elisio-HX integrates into existing haemodialysis infrastructure and established clinical workflows, providers can adopt HDs without investing in new dialysis machines or fundamentally changing the way dialysis is delivered.
