Subject: FDA
FDA Clears VersitmPD Cycler System from Fresenius Medical Care North America
Smallest, Lightest, and Quietest Peritoneal Dialysis Cycler Aims to Accelerate Adoption of Home Therapy
WALTHAM, Mass., April 21, 2022 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has awarded 510(k) clearance to the VersitmPD Cycler System*, a next generation portable automated peritoneal dialysis (APD) system from Fresenius Medical Care North America (FMCNA). VersiPD is the lightest, smallest, and quietest dialysis cycler in the United States.
As the nation's leading provider of kidney care products, Fresenius Medical Care is developing new innovative technologies that are designed to accelerate 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, and is designed to improve health equity by making home therapy a more feasible option for a broader population of dialysis patients.
"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. "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 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 a patient's quality of life.
VersiPD is supported by the Kinexustm Therapy Management Platform, a connected health system that aims to improve patient outcomes and nurse 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 hospitalizations, technique failure, and patient dropout; and increased average patient's length of stay on peritoneal dialysis.1, 2
"We believe that our new VersiPD 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 Dr. Mike Anger, Chief Medical Officer for FMCNA's Renal Therapies Group. "We know most patients can be successful dialyzing at home with the right technology and support, and this new cycler is an important milestone in our journey to truly transform dialysis care."
VersiPD will begin a limited rollout in 2022 with more widespread availability planned in 2023 and beyond.
For more information about FMCNA products, please visit: https://fmcna.com/versipd
- 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
- 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
Indications for Use: The VersitmPD Cycler System is indicated for adult chronic peritoneal dialysis in home and clinical settings.
Note: Read the Instructions for Use for safe and proper use of this device. For a complete description of hazards, contraindications, side effects, and precautions, see full package labeling at fmcna.com.
Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
Use: The Kinexus Portal is intended to allow clinicians to review patient data collected from the patient's home dialysis device(s) and to enable physicians to manage patients' home dialysis therapies for certain Fresenius products, including peritoneal dialysis cycler(s). The Kinexus Portal does not provide medical diagnoses or recommendations regarding medical treatment. The Kinexus Portal and the content appearing on this site are not substitutes for professional medical advice, diagnosis, or treatment.
Use: The Kinexus Gateway is intended for transmission of home dialysis therapy data and patient data for patients using certain Fresenius products, including peritoneal dialysis cycler(s).
* Previously known as Lilliputtm APD System
About Fresenius Medical Care North America
Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities and outpatient cardiac and vascular labs, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world's largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com/.
Disclaimer
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 certain factors, including changes in business, economic and competitive conditions, regulatory reforms, 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.
Media Contact:
Brad Puffer
Fresenius Medical Care North America
781-699-3331
[email protected]
SOURCE Fresenius Medical Care Holdings, Inc.
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