- Fresenius Medical Care (FME) receives U.S. Food and Drug
Administration (FDA) 510(k) clearance of the company's 5008X
Hemodialysis System.
- This will enable Fresenius Medical Care to offer the
industry-leading, high-volume hemodiafiltration (Hv-HDF) dialysis
therapy – already widely used in Europe – for people living with kidney
diseases in the U.S.
- The 510(k) clearance allows the start of clinical evaluations
and user-studies in the U.S., with a planned broad commercial
launch of the 5008X Hemodialysis System in 2025.
- The 5008X Hemodialysis System and companion FX CorAL dialyzer
demonstrate the company's global innovation leadership in medical
device and membrane engineering technologies.
BAD HOMBURG, Germany, Feb. 8, 2024
/PRNewswire/ -- Fresenius Medical Care (FME), the world's leading
provider of products and services for individuals with renal
diseases, today announced the company has received U.S. Food and
Drug Administration (FDA) 510(k) clearance for the company's 5008X
Hemodialysis System. Now the company wants to bring a new standard
of care in dialysis therapy to people living with kidney diseases
in the U.S.
"Making new and innovative therapies available to patients is
core to our goal of improving the lives of people living with
kidney diseases," says Helen
Giza, CEO for Fresenius Medical Care AG. "The 5008X
Hemodialysis System demonstrates our company's ability to innovate
at scale. This innovation builds on the proven track record of our
hemodialysis system series in Europe, Latin
America and Asia Pacific."
Helen Giza says: "We're pleased to
achieve this important milestone to bring a new standard of care in
dialysis therapy to one of the world's largest healthcare markets,
where there is significant opportunity to make meaningful
impact."
Dialysis is a life-saving treatment for people whose kidneys are
failing and who can no longer naturally filter their blood in order
to remove excess water, solutes, and toxins from the body. Unlike
conventional high-flux hemodialysis, which primarily employs
diffusion to remove small molecules and fluid from the blood,
high-volume hemodiafiltration incorporates both diffusion and
convection techniques to eliminate larger molecules and effectively
manage fluid replacement through convection.
The results of the recently published groundbreaking
CONVINCE* study demonstrated that patients treated with
high-volume hemodiafiltration experienced a remarkable 23% decrease
in mortality rates compared to those treated with the more commonly
used high-flux hemodialysis. This study was a multinational
research study that compared these two types of hemodialysis
techniques. It was a three-year trial performed at 61 dialysis
centers in eight European countries.
Cleared for the start of U.S.-based clinical evaluations and
user studies ahead of a planned broad market launch in 2025, the
5008X Hemodialysis System is one of Fresenius Medical Care's latest
medical device innovations, capable of providing industry-leading,
high-volume hemodiafiltration dialysis therapy. Along with the
companion FX CorAL dialyzer - already registered in the U.S. -, the
5008X Hemodialysis System combines the latest device engineering
and cutting-edge membrane technologies required to make high-volume
hemodiafiltration possible.
In the U.S. there is currently an estimated installed base of
around 160.000 in-center hemodialysis machines across all service
providers that could be replaced to adapt this new standard of
care.
About Fresenius Medical Care:
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 and is the leading provider of dialysis
products such as dialysis machines and 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.
*Funded by the European Union, conducted by the CONVINCE
consortium, and led by the University Medical Center Utrecht, the
international, randomized controlled CONVINCE trial marked a
crucial milestone in comparing high-volume hemodiafiltration with
standard, high-flux hemodialysis.
The information in this document is provided as is and no
guarantee or warranty is given that the information is fit for any
particular purpose. The user thereof uses the information at its
sole risk and liability. The opinions expressed in the document are
of the authors only and in no way reflect the European Commission's
opinions.
The CONVINCE study was exclusively supported by the European
Commission Research & Innovation, Horizon 2020, Call
H2020-SC1-2016-2017 under the topic SC1-PM-10-2017: Comparing the
effectiveness of existing healthcare interventions in the adult
population (grant no 754803).
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's reports filed with the
U.S. Securities and Exchange Commission. Fresenius Medical Care
does not undertake any responsibility to update the forward-looking
statements in this release.
Media contact
Christine Peters
T +49 160 60 66 770
christine.peters@freseniusmedicalcare.com
Emanuela Cariolagian
T +1 213 706 0051
emanuela.cariolagian1@freseniusmedicalcare.com
Contact for analysts and investors
Ilia Kürten
T +49 6172 268 59 66 ilia.kuerten@freseniusmedicalcare.com
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SOURCE Fresenius Medical Care Holdings, Inc.
