Fresenius Medical Care Receives FDA Clearance for Versi™PD Cycler System

Press release

Fresenius Medical Care, the world’s leading provider of products and services for people with kidney disease, today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance to the system Versi™PD Cycler1. This next-generation portable automated peritoneal dialysis system from Fresenius Medical Care North America is the lightest, smallest, and quietest dialysis cycler in the United States.

As the leading provider of kidney care products in the United States, Fresenius Medical Care develops innovative new technologies designed to accelerate the growth of home therapies by making home dialysis systems smarter, more intuitive and easier to use. for people with kidney failure. VersiPD is simple, quiet, portable and advanced. VersiPD is also designed to improve health equity by making home therapy a more feasible option for a broader population of dialysis patients.

Designed from the ground up to improve the patient experience, VersiPD will allow patients to enjoy restful sleep with its near-silent operation, fewer disruptive alarms and night mode. The cycler has the ability to program more personalized prescriptions to meet the individual needs of a wide range of patients. VersiPD offers a large touchscreen with an intuitive design as well as integrated videos with audio guidance to help patients step by step through setup and treatment. The cycler’s battery and custom cart facilitate mobility around the home, which can further improve the patient’s quality of life.

VersiPD is supported by the Kinexus™ Therapy Management Platform, a connected healthcare system that aims to improve patient outcomes and nurse productivity through remote therapy monitoring and scheduling capabilities. The Kinexus platform is also available with the Liberty® Select cycler and is designed to be fully compatible with the company’s future portfolio of home dialysis machines. Connected health is associated with reduced rates of hospitalization, technical failure and patient dropout, and an increase in the average length of stay for patients on peritoneal dialysis.2.3

A limited rollout of VersiPD will begin this year, with wider availability expected in 2023 and beyond. The company also plans to roll out VersiPD in other regions of the world in the future.

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