FDA Clears New Quiet, Portable Dialysis System

The US Food and Drug Administration (FDA) has cleared a new portable automated peritoneal dialysis platform that is said to be the lightest, smallest, and quietest dialysis cycler in the US.

Improving Quality of Life

The clearance for the Versi PD Cycler System, developed by Fresenius Medical Care North America, could potentially improve the quality of life for patients on dialysis by improving sleep with its quiet operation, fewer disruptive alarms, and night mode option.

The new system is used along with the Kinexus Therapy Management Platform, a system that allows remote therapy monitoring and programming.

The cycler can also be personalized for prescription programing to meet the needs of individual patients. The system also includes a large, intuitively designed touchscreen with the capacity for embedded videos and audio guidance to assist patients through setup and treatment.

The battery and custom cart also allow mobility around the home to further improve the quality of life for the patient.

Reactions

Officials from Fresenius said the clearance could help improve health equity across the country.

“The clearance of VersiPD is another important step in our effort to make home therapies easier for patients and more efficient for clinicians,” said Joe Turk, President of FMCNA’s Renal Therapies Group, in a statement. “We have listened closely to what patients and clinicians want in a home dialysis experience and have brought those ideas into the heart of this innovative system.”

The Versi PD Cycler System is expected to become available at some point in 2022, with more widespread availability planned for 2023.