New medium-cutoff Dialyzer with a super high-flux membrane brings NIPRO's approach to expanded hemodialysis to United States healthcare providers.
Osaka, Japan – 30/07/2026 — NIPRO CORPORATION has been granted 510(k) clearance for the ELISIO-HX dialyzer by the United States Food and Drug Administration (FDA), effective July 28, 2026. The clearance enables the introduction of HDs (Hemodialysis powered by super high-flux membrane) in the United States. HDs is NIPRO's approach within expanded hemodialysis (Expanded HD), providing healthcare professionals with a practical way to enhance hemodialysis while using existing dialysis infrastructure and established clinical workflows.
Expanded hemodialysis (Expanded HD) is an approach to hemodialysis designed to extend the removal of larger middle molecules beyond conventional high-flux dialysis. HDs combines 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.
Making expanded hemodialysis more accessible
At the core of HDs is the ELISIO-HX dialyzer, 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 hemodialysis systems. Because ELISIO-HX integrates into existing hemodialysis infrastructure and established clinical workflows, providers can adopt HDs without investing in new dialysis machines or fundamentally changing the way dialysis is delivered.
Innovation creates its greatest value when it becomes accessible in everyday clinical practice.
Our ambition is to broaden the number of patients who can benefit from enhanced hemodialysis. With HDs, enabled by ELISIO-HX and our proprietary super high-flux membrane technology, healthcare professionals can enhance hemodialysis using the infrastructure and expertise they already have. FDA clearance represents an important milestone in bringing this approach to patients across the United States.
Building on global experience
The introduction of HDs to the United States market builds on clinical and real-world experience with ELISIO-HX across Japan, Europe and Latin America, demonstrating its applicability in a variety of healthcare settings.
Our experience across multiple regions has shown that HDs can be successfully integrated into routine dialysis care.
Introducing ELISIO-HX in the United States represents another important step in making advanced dialysis technologies available to more patients while supporting healthcare professionals in delivering high-quality care.
Helping more patients benefit from expanded hemodialysis
The United States is home to one of the world's largest populations of patients receiving maintenance hemodialysis. FDA clearance of ELISIO-HX enables NIPRO to introduce HDs to this important market, providing dialysis providers with an additional approach within expanded hemodialysis that integrates seamlessly into existing models of care.
By combining proprietary membrane engineering with broad patient eligibility and compatibility across conventional hemodialysis systems, HDs enables healthcare providers to extend the benefits of expanded hemodialysis across a wide spectrum of patients without adding complexity to routine clinical practice.
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.
This milestone reflects NIPRO's commitment to developing practical solutions that help healthcare professionals deliver better care to more patients. By making enhanced dialysis care more accessible, we continue to contribute to our promise of helping people live longer and better lives.
Media Contacts:
Annick Somers | Global Marketing & Communications
[email protected]
David Reese| Americas Marketing & Communications
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Frequently Asked Questions (FAQs)
ELISIO™-HX is NIPRO’s proprietary super high-flux dialyzer and the technology behind HDs: Hemodialysis powered by super high-flux membrane.
It is designed to extend the removal of larger middle molecule uremic toxins beyond conventional high-flux hemodialysis while maintaining albumin retention.
ELISIO™-HX is built on the Polynephron™ membrane, a precisely engineered sharp cut-off polyethersulfone membrane. It removes a broad range of middle molecules, including beta-2 microglobulin, free light chains and myoglobin, while limiting albumin loss to less than 1 gram per treatment session.
In Japan, ELISIO™-HX belongs to the Type IIa super high-flux category (formerly Class V).
Clinical study data covering more than 200,000 patients have associated IIa dialyzers with statistically significant reductions in all-cause mortality risk compared with Class IV dialyzers.
HDs stands for Hemodialysis powered by super high-flux membrane.
The “s” refers to super high-flux, the advanced membrane category that enables the treatment performance of HDs.
HDs is NIPRO’s approach within Expanded HD. It uses the ELISIO™-HX super high-flux dialyzer and NIPRO’s proprietary membrane technology to extend the removal of larger middle molecules beyond conventional high-flux dialysis while maintaining albumin retention.
The concept is deliberately simple: enhanced dialysis performance is delivered through the membrane itself, without requiring a new treatment platform, specialized equipment or fundamental changes to established hemodialysis workflows.
Super high-flux describes a class of dialysis membrane engineered to remove a broader range of middle molecules than conventional high-flux membranes.
Our specific membrane has a precisely controlled pore structure that extends the removal of larger middle molecules, particularly those in the approximately 12 to 60 kDa range, while maintaining controlled albumin loss.
In Japan, super high-flux dialyzers are designated IIa. ELISIO™-HX belongs to this category.
Expanded HD is the broader treatment approach of extending the removal of larger middle molecules beyond conventional high-flux hemodialysis.
HDs is NIPRO’s specific implementation of this approach.
It combines ELISIO™-HX with NIPRO’s super high-flux membrane technology to deliver enhanced middle molecule clearance within standard hemodialysis practice.
This means that HDs can be introduced through existing hemodialysis infrastructure and established clinical workflows, without requiring new equipment or major changes to care delivery.
FDA 510(k) clearance authorizes NIPRO to market the ELISIO™-HX dialyzer in the United States.
This enables NIPRO to introduce HDs into one of the world’s largest dialysis markets and represents an important commercial and strategic milestone for the company.
Commercial availability will follow the completion of standard commercial readiness activities.
The clearance also strengthens NIPRO’s position in advanced dialysis therapy by bringing a differentiated membrane-based treatment approach to the U.S. market.
The clearance of ELISIO™-HX allows NIPRO to introduce HDs through a product that fits within existing care models.
This is strategically important because it combines enhanced membrane performance with operational simplicity. Dialysis providers can introduce HDs without replacing existing machines, redesigning treatment workflows or making additional capital investments.
This creates the potential for scalable adoption across U.S. dialysis provider networks.
ELISIO™-HX combines enhanced middle molecule clearance with a sharp cut-off membrane technology
Three characteristics distinguish ELISIO™-HX in the U.S. market:
1. Sharp cut-off membrane design
The Polynephron™ membrane delivers broad middle molecule removal while limiting albumin loss to less than 1 gram per treatment session.
2. Broad patient eligibility
Approximately 95% of hemodialysis patients are eligible for treatment with ELISIO™-HX, including patients who may be unable to receive HDF because of vascular, clinical or volume-related constraints.
3. Infrastructure compatibility
ELISIO™-HX is compatible with existing hemodialysis systems and requires no new dialysis equipment, specialized infrastructure or additional capital investment.
Together, these characteristics make HDs both clinically differentiated and operationally scalable.
ELISIO™ HX has been used clinically across Japan, Europe and Latin America and has been integrated into routine dialysis care across a range of healthcare settings.
In Japan, super high-flux dialyzers are used in the treatment of more than 90% of hemodialysis patients.
This broad clinical experience provides an important foundation for the introduction of ELISIO™-HX and HDs in the United States.
It also demonstrates that the treatment approach can be incorporated into existing dialysis infrastructure and workflows across diverse healthcare systems.
The clearance of ELISIO™-HX reflects NIPRO’s long-term commitment to advancing dialysis therapy and creating the new normal in dialysis.
HDs is based on the principle that enhanced dialysis performance can be delivered through the dialyzer itself.
This approach allows NIPRO to combine clinical differentiation with operational simplicity, broad patient eligibility and scalable implementation.
The introduction of HDs in the United States builds on decades of experience across Japan, Europe and Latin America and supports NIPRO’s mission to help people live longer and live better.
