WALTHAM,
Mass., Aug. 23, 2023 /PRNewswire/ -- Fresenius
Medical Care, the world's leading provider of products and services
for individuals with renal diseases, today announced the U.S. Food
and Drug Administration (FDA) 510(k) clearance for
Versi®HD with GuideMe Software, a completely reinvented
self-guided interface for the company's VersiHD chronic home
hemodialysis (HHD) system. VersiHD with GuideMe Software aims to
transform the experience of HHD for patients and nurses.
As the established leader in HHD, NxStage from Fresenius
Medical Care, draws on its experience of over 30 million patient
treatments at home over nearly two decades, serving patients in
more than 45,000 homes with a broad diversity of water sources
across the U.S.
VersiHD with GuideMe Software provides graphical walk-through
guidance that aims to enhance ease of use and confidence for both
patients and nurses. It is designed to improve patient training
time, ease the transition to home, and make the training experience
easier for new users.
"With over 13,000 HHD patients in the U.S. alone, we are
excited to amplify the innovation NxStage offers with advanced
technologies, like VersiHD with GuideMe Software," said Dr.
Katarzyna Mazur-Hofsäß, CEO of Fresenius Medical Care's Care
Enablement segment. "We are committed to providing cutting-edge
solutions to improve the health and well-being of dialysis patients
by challenging the standard of home dialysis with the design of
industry-leading products."
"We expect VersiHD with GuideMe Software to further simplify
home hemodialysis for patients during training and at home," said
Dr. Brigitte Schiller, Senior Vice
President, Medical Officer, Home Therapies at Fresenius Medical
Care. "As a result of this software upgrade, patients and their
care partners will have additional support to be confident with the
therapy at home. VersiHD with GuideMe Software will support
Fresenius Medical Care's mission of advancing access to home
therapies to more patients."
NxStage has had many significant innovations over the years
guided by patient input starting with the first portable HHD
machine, NxStage System One™, in 2005 followed by the
introduction of the PureFlow™ DI Water Purification
System in 2006. Nx2me Connected Health®, the first
Connected Health platform for HHD followed in 2014. The NxStage
System One was the first machine to receive FDA clearance for
Nocturnal HHD indication in 2014 and also the first to receive FDA
clearance for Solo HHD indication in 2017. In 2017, NxStage
introduced the VersiHD touchscreen cycler. Over 95% of HHD patients
in the U.S. use the NxStage HHD system.
VersiHD with GuideMe Software will initially be available in
selected markets in 2023. Existing VersiHD systems will be
upgradeable to GuideMe Software. For more information about VersiHD
with GuideMe Software, please visit
www.nxstage.com/hcp/versihdguideme
Despite the health benefits that home hemodialysis may provide
to those with chronic kidney disease, this form of therapy is not
for everyone. The reported benefits of home hemodialysis may not be
experienced by all patients. The risks associated with hemodialysis
treatments in any environment include, but are not limited to, high
blood pressure, fluid overload, low blood pressure, heart-related
issues, and vascular access complications. The medical devices used
in hemodialysis therapies may add additional risks including
air entering the bloodstream and blood loss due to clotting or
accidental disconnection of the blood tubing set. Certain risks are
unique to the home. Treatments at home are done without the
presence of medical personnel and on-site technical support.
Patients and their partners must be trained on what to do and how
to get medical or technical help if needed.
© 2023 Fresenius Medical Care. All Rights Reserved.
Fresenius Medical Care, NxStage, the triangle logo, VersiHD,
PureFlow and Nx2me are trademarks of Fresenius Medical Care
Holdings, Inc. or its affiliated companies. All other trademarks
are the property of their respective owners.
Fresenius Medical Care is the world's leading provider of
products and services for individuals with renal diseases of which
around 3.9 million patients worldwide regularly undergo dialysis
treatment. Through its network of 4,050 dialysis clinics, Fresenius
Medical Care provides dialysis treatments for approximately 344,000
patients around the globe. Fresenius Medical Care is also the
leading provider of dialysis products such as dialysis machines or
dialyzers. Fresenius Medical Care is listed on the Frankfurt Stock
Exchange (FME) and on the New York Stock Exchange (FMS).
For more information visit the Company's website
at www.freseniusmedicalcare.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 various factors, including, but not limited to, changes in
business, economic and competitive conditions, legal changes,
regulatory approvals, impacts related to the COVID-19 pandemic
results of clinical studies, 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
Leif
Heussen
T +49 6172 608-4030
leif.heussen@fresenius.com
Emanuela Cariolagian
T +1 800 723-2384
media@freseniusmedicalcare.com
Contact for analysts and investors
Dr. Dominik Heger
T +49 6172 609-2601
dominik.heger@fmc-ag.com
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SOURCE Fresenius Medical Care Holdings, Inc.
