Fresenius Medical Care North America (FMCNA) has received the US Food and Drug Administration (FDA) 510(k) clearance for its VersiPD Cycler System.
The portable automated peritoneal dialysis (APD) system is claimed to be the lightest, smallest and quietest dialysis cycler available in the US.
Fresenius Medical Care, which provides products and services for individuals with renal diseases, aims to make the home dialysis systems smarter, more intuitive and easier to use for people living with kidney failure.
VersiPD aims to enhance health equity by making home therapy a more viable choice for a larger group of dialysis patients.
According to Fresenius Medical Care, the system is designed to improve the patient experience and comfort level due to its quiet operation, less intrusive alarms, and night mode.
VersiPD can provide more individualised prescription programming to meet the demands of a wide variety of patients.
It also has a touchscreen as well as videos with voice advice to guide patients through the setup and treatment process.
The cycler battery and custom cart make it easier to move around the house, which can enhance the patient’s quality of life even more.
VersiPD is backed by the Kinexus Therapy Management Platform, a connected health system that enhances patient outcomes and nurse efficiency by enabling remote therapy monitoring and programming.
The Kinexus platform, also available with the Liberty Select Cycler, is designed to be fully compatible with the company’s future home dialysis equipment, said Fresenius Medical Care.
The company will begin the limited rollout of VersiPD in 2022 with more widespread availability planned in 2023 and beyond. It has plans to spread the access to other regions of the world in the future.
