April 21, 2022
Fresenius Medical Care receives FDA clearance for Versi™PD Cycler System
Fresenius Medical Care, the world's leading provider of products and services for individuals with renal diseases, announced today that the U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance to the Versi™PD Cycler System1. 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 U.S., Fresenius Medical Care is developing new, innovative technologies designed to accelerate the growth of home therapies by making home dialysis systems smarter, more intuitive and easier to use for people living 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 enhance the patient experience, VersiPD will allow patients to enjoy restful sleep through its almost silent operation, fewer disruptive alarms and night mode. The cycler has the capability of more personalized prescription programming to meet the individual needs of a broad range of patients. VersiPD offers a large, intuitively designed touchscreen as well as embedded videos with audio guidance to assist patients step-by-step through setup and treatment. The cycler 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 health system that aims to improve patient outcomes and nurses’ productivity through remote therapy monitoring and programming 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, technique failure and patient dropout, and an increased average patient length of stay on peritoneal dialysis.2,3
A limited rollout of VersiPD will begin this year, with wider availability planned in 2023 and beyond. The company also plans to roll out VersiPD in other regions around the world in the future.
1 Previously known as Lilliput™ APD System
2 Chaudhuri S, Han H, Muchiutti C, et al. Remote Treatment Monitoring on Hospitalization and Technique Failure Rates in Peritoneal Dialysis Patients. Kidney360. 2020;1(3):191 LP - 202. doi:10.34067/KID.0000302019
3 Giles H, Ficociello L, Li Y, Ofsthun N, Kossmann R. Remote Patient Monitoring and Longevity on Peritoneal Dialysis [Abstract presented at 39th Annual Dialysis Conference]. Perit Dial Int. 2019;39(1_suppl): S4. doi:10.1177/089686081903901s01
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, impacts related to the COVID-19 pandemic results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.