11/16/2021 | Press release | Distributed by Public on 11/16/2021 02:27
Nov. 16, 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. |
Trade Name | : FILTRYZER HDF |
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. |