# NIPRO CORPORATION Receives FDA 510(k) Clearance for ELISIO™-HX, Introducing HDs to the United States

- Link: https://www.thailand-business-news.com/pr-news/nipro-corporation-receives-fda-510k-clearance-for-elisio-hx-introducing-hds-to-the-united-states
- Published: 2026-07-30T19:10:00+07:00
- Author: PR Newswire

New medium-cutoff Dialyzer with a Super High-flux membrane brings NIPRO’s approach
to expanded hemodialysis to United States healthcare providers. 

OSAKA, Japan, July 30, 2026 /PRNewswire/ — 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.

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.

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," said Tsuyoshi Yamazaki, President & CEO of NIPRO CORPORATION. "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."_

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," said Goichi Miyazumi, President of NIPRO’s
Medical Business Global Division. "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."_

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.

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