Nipro Receives FDA Clearance for ELISIO™-HX Dialyzer
NIPRO CORPORATION has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ELISIO™-HX dialyzer. This clearance allows the introduction of the company's expanded hemodialysis approach to U.S. healthcare providers.
NIPRO CORPORATION announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ELISIO™-HX dialyzer. This marks a significant step for the company, enabling the distribution of its new medium-cutoff dialyzer featuring a Super High-flux membrane to healthcare providers across the United States.
The ELISIO™-HX dialyzer is designed to advance the field of expanded hemodialysis. The technology aims to provide patients with enhanced treatment options, potentially improving the efficacy of dialysis and the overall quality of life for individuals managing kidney disease. Specific details regarding pricing and market availability in the U.S. were not disclosed by the company.
Based in Osaka, Japan, NIPRO CORPORATION is a manufacturer of medical devices with a focus on nephrology products. The FDA clearance for the ELISIO™-HX dialyzer represents a strategic expansion for NIPRO into the U.S. market, furthering its commitment to kidney care solutions.