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Liberty Select with Kinexus Receives FDA Clearance for Remote Therapy Management
WALTHAM, Mass., Nov. 2, 2022 /PRNewswire/ -- Fresenius Medical Care North America (FMCNA), the nation's leading dialysis products company, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance upgrading the company's Liberty® Select Cycler to enable remote therapy management with the Kinexus® Therapy Management Platform. This upgrade is designed to elevate the home therapy experience for peritoneal dialysis (PD) patients and clinicians.1
"This is the latest in a series of significant innovations in our portfolio of home dialysis machines that we believe will play a critical role in accelerating the adoption of home therapies and improving patient outcomes," said Joe Turk, Global Head of Home Therapies at Fresenius Medical Care. "Our new PD system has remote therapy management capabilities allowing clinicians to modify the patients' therapy program remotely, helping patients reduce in-person appointments."
Liberty® Select with Kinexus® assists home dialysis clinicians to make critical, informed decisions from accurate, timely treatment data summaries. Care Teams will also have access to up to 90 days of treatment data history to help assess program effectiveness. When needed, the dialysis provider can adjust the therapy program for prompt, data driven interventions. Liberty Select cyclers in the market can be upgraded to enable remote therapy management.
In addition, Liberty Select with Kinexus is simple, safe, and connected. It offers patients a more personalized therapy experience, including daily patient health inputs, customizable drain options, flow alert options designed to reduce alarms and alerts at night, as well as more visibility to total ultrafiltration. Additionally, the cycler includes an intuitive user interface on a large, color touchscreen offering step-by-step instructions that guide the patient through setup, treatment, and troubleshooting.
"We expect these new features will make patients more willing to try peritoneal dialysis and find success, ultimately improving their quality of life," said Dr. Dinesh Chatoth, Associate Chief Medical Officer for Fresenius Kidney Care. "As a result of these updates, providers can more easily make timely prescription changes in the first several months of PD therapy, which our research shows may reduce attrition rates among patients by almost 90%." 2
Kinexus has received patient data for over one million treatments. The use of connected health platforms, such as Kinexus, may reduce hospitalizations and technique failure, as well as lead to fewer patient dropouts and increased longevity on peritoneal dialysis.3,4 FMCNA is committed to improving health equity by enabling access to home therapies with machines that are more intuitive and more feasible to use for a broader population of dialysis patients.
The upgraded PD cycler complements the company's growing portfolio of home dialysis machines with connected health capabilities, offering a wider range of options for providers to consider when evaluating the best treatment for each patient. Recently, the FDA also cleared the company's new Versi™PD Cycler System which is expected to be more widely available in the future.
For more information about Liberty Select with Kinexus, please visit: https://fmcna.com/liberty-select/
References:Indications for Use: <The Fresenius Liberty Select cycler is indicated for acute and chronic peritoneal dialysis.>
Caution: Federal (U.S.) law restricts these devices to sale by or on the order of a physician.
Note: Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects, and precautions, see full package labeling at www.fmcna.com.
Use: The Kinexus Portal is intended to allow clinicians to review patient data collected from the patients' 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.
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).
Kinexus is not an electronic health record (EHR) or billing solution.
Liberty® Select with Kinexus® is distributed by NxStage Medical, Inc., a subsidiary of Fresenius Medical Care.
© 2022 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, Kinexus, Liberty Select, Liberty, and VersiPD are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners.
About Fresenius Medical Care North AmericaFresenius 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/.
DisclaimerThis 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:
Fresenius Medical Care North America
Scott Sayres
VP, Corporate Communications
scott.sayres@freseniusmedicalcare.com
+1 (940) 297-5678
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SOURCE Fresenius Medical Care Holdings, Inc.