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FDA Clears Fresenius Medical Care North America’s Versi™PD Cycler System

As the nation’s leading supplier of kidney care products, Fresenius Medical Care develops innovative new technologies designed to accelerate the growth of home therapies by making home dialysis systems smarter, more intuitive and easier for people to use. suffering from 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 wider population of dialysis patients.

“The clearance of VersiPD is another important step in our efforts to make home therapies easier for patients and more effective for clinicians,” said Joe Turkish, chair of FMCNA’s Renal Therapy Group. “We listened carefully to what patients and clinicians want from a home dialysis experience and incorporated those ideas into the heart of this innovative system.”

Designed from the ground up to improve the patient experience, VersiPD will allow patients to enjoy restful sleep with its near-silent operation, fewer disruptive alarms and night mode. The cycler has the ability to program more personalized prescriptions to meet the individual needs of a wide range of patients. VersiPD offers a large touchscreen with an intuitive design, as well as integrated videos with audio guidance to help patients step by step through setup and treatment. The cycler’s 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 healthcare 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 devices. Connected health is associated with a reduction in hospitalizations, technical failures and patient abandonments; and increasing the average length of stay for patients on peritoneal dialysis.1, 2

“We believe that our new VersiPD will allow more patients to regain their freedom and independence, while enabling healthcare teams to better support patients and intervene more quickly if necessary,” said Dr. Mike Anger, physician-in-chief of FMCNA’s Renal Therapy Group. “We know that most patients can be successful on home dialysis with the right technology and support, and this new cycler is an important step in our journey towards truly transforming dialysis care.

VersiPD will begin a limited rollout in 2022 with broader availability expected in 2023 and beyond.

For more information on FMCNA products, please visit: https://fmcna.com/versipd

  1. Chaudhuri S, Han H, Muchiutti C, et al. Remote treatment monitoring on hospitalization and technique failure rates in patients on peritoneal dialysis. Kidney360. 2020;1(3):191 LP – 202. doi:10.34067/KID.0000302019
  2. 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 Versi™PD Cycler System is indicated for adult chronic peritoneal dialysis in the home and clinical setting.

To note: Read the user instructions for safe and proper use of this device. For a full description of hazards, contraindications, side effects, and precautions, see the full package labeling at fmcna.com.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Utilize: The Kinexus Portal is intended to allow clinicians to review patient data collected from the patient’s home dialysis machine(s) and to allow physicians to manage patients’ home dialysis therapies for certain Fresenius products, including including peritoneal dialysis cyclers. The Kinexus Portal does not provide medical diagnoses or recommendations for medical treatment. The Kinexus portal and the content appearing on this site is not a substitute for professional medical advice, diagnosis or treatment.

Utilize: The Kinexus Gateway is intended for the transmission of home dialysis treatment data and patient data for patients using certain Fresenius products, including peritoneal dialysis cyclers.

* Formerly known as Lilliput™ 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 for people with kidney disease and other chronic conditions. Through its industry-leading network of dialysis facilities and ambulatory cardiac and vascular laboratories, Fresenius Medical Care North America provides coordinated health care services at essential points of care for hundreds of thousands of customers. chronically ill across the continent. As the world’s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most complete line of dialysis equipment, disposables and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com/.

Warning
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, exchange rate fluctuations, uncertainties in litigation or proceedings. investigation and the availability of funding. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the United States Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA disclaims any responsibility for updating the forward-looking statements contained 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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