The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fresenius Medical Care North America (FMCNA) for its Versi peritoneal dialysis (PD) cycler system—a next-generation, portable automated peritoneal dialysis (APD) system.
Fresenius claims that Versi PD is “the lightest, smallest and quietest dialysis cycler in the USA”. The simple, portable device is designed to improve health equity by making home therapy a more feasible option for a broader population of dialysis patients.
“The clearance of Versi PD 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. “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.”
Designed to enhance the patient experience, Versi PD will allow patients to enjoy restful sleep through its almost silent operation, fewer disruptive alarms, and night mode, according to a Fresenius press release. The cycler also has the capability of more personalised prescription programming to meet the individual needs of a broad range of patients. It 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 a patient’s quality of life, the release details.
“We believe that our new Versi PD will empower more patients to reclaim their freedom and independence, while further enabling care teams to better support patients and intervene more quickly when necessary,” said Mike Anger, chief medical officer for FMCNA’s Renal Therapies Group. “We know most patients can be successful dialysing at home with the right technology and support, and this new cycler is an important milestone in our journey to truly transform dialysis care.”
Versi PD will begin a limited rollout in 2022, with more widespread availability planned in 2023 and beyond, according to Fresenius.