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Toray Debuts Japan’s First PMMA Hemodiafiltration Device

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Nov. 16, 2021

Toray Industries, Inc.
Toray Medical Co., Ltd.

Tokyo, Japan, November 15, 2021 – Toray Industries, Inc., announced today that it has developed FILTRYZER® HDF, Japan’s first polymethyl methacrylate (PMMA) hollow fiber membrane-based (see Glossary note 1) hemodiafiltration device. The wholly owned Toray Medical Co., Ltd., will begin marketing this new offering in December 2021.
Following extensive hemodiafiltration development efforts leveraging its technologies, in August 2021 the company obtained manufacturing and sales approval for this product, which qualified for insurance coverage as of November 1.

Broadly two therapies employ artificial kidneys (Glossary note 2). The first is hemodialysis (Glossary note 3) with dialyzers. The second is hemodiafiltration (Glossary note 4) with hemodiafilters, which combines hemofiltration and hemodialysis. The Japan Society for Dialysis Therapy estimates that the hemodiafiltration devices accounted for 42% of the market at the end of 2019.

More than 80% of hollow fiber membranes in hemodiafilters in Japan are made of polysulfone (Glossary note 5). Demand has risen for other materials, including because of allergic reactions and other biocompatibility (Glossary note 6) issues and uremic toxin removal (Glossary note 7) performance needs.

Toray is the world’s sole manufacturer of dialyzers incorporating PMMA hollow fiber membranes. They have earned excellent reputations in Japan and numerous other nations for excellent biocompatibility and uremic toxin removal.

In 2007, the company obtained approval to manufacture and sell Japan’s first polysulfone hollow fiber membrane hemodiafilters, thereafter evolving them. The new PMMA hemodiafiltration device underscores its ongoing commitment to meeting diversifying dialysis market needs.

Under Toray Group Sustainability Vision, the company seeks to contribute to better medical care and hygiene for people worldwide by leveraging its innovative technologies and advanced materials. Toray and Toray Medical will keep drawing on these capabilities in developing high value-added medical supplies using advanced material technologies to materialize its corporate philosophy of contributing to society through the creation of new value and thereby increase sustainable growth.

Product details
Generic name : Hemodiafiltration device
Medical Device Approval Number : 30300BZX00233000
Classification : Class III, Japan

1. PMMA hollow fiber membranes
Semi-permeable membranes for artificial kidneys can be biological or synthetic, the latter predominating because of easier removal and biocompatibility. PMMA is highly biocompatible, one notable application being intraocular lenses.
2. Artificial kidneys
These dialyzers provide extracorporeal hemodialysis for people with renal failure. They employ semipermeable membrane diffusion to remove waste from the blood and excess fluid from the body. Flat and hollow fiber dialyzers are available. The latter type comprises a bundle of around 10,000 fibers, each with an inner diameter of 200 micrometers.
3. Hemodialysis 
With this procedure, blood flows through semipermeable membranes into dialysate to remove blood waste through diffusion.
4. Hemodiafiltration
This combines filtration and hemodialysis, and is better than regular hemodialysis at removing beta-2 microglobulin and other substances with high molecular weights.
5. Polysulfone hollow fiber membrane
Polysulfone is a high-performance thermoplastic polymer. Polysulfone hollow fiber membranes for artificial kidneys are common because of their outstanding ability to remove uremic toxins ranging from urea and other low-molecular-weight substances to such high-molecular-weight substances as beta-2 microglobulin.
6. Biocompatibility
Biocompatibility refers to biological reactions when blood contacts semipermeable membranes. Assessments encompass such indicators as white blood cell count changes and platelet and complement activation. A membrane with good biocompatibility resists biological reactions during dialysis.
7. Uremic toxin 
These substances accumulate in the bloodstream. The body cannot eliminate them during renal failure, causing a range of problems. In the early days of dialysis therapy, the prime targets were urea, with a molecular weight of 60, and other substances with low molecular weights. Treatment has broadened to include substances with high molecular weights, which are also called low-molecular-weight proteins. One is beta-2 microglobulin, with a molecular weight of 12,000.

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