Baxter Completes CE Mark Approval for VIVIA Hemodialysis System in Europe

  Baxter Completes CE Mark Approval for VIVIA Hemodialysis System in Europe

    Home hemodialysis device designed to deliver more frequent or extended
                              duration dialysis

Business Wire

DEERFIELD, Ill. -- December 20, 2013

Baxter International Inc. (NYSE:BAX) today announced completion of CE marking
in Europe for the VIVIA hemodialysis (HD) system, designed to deliver more
frequent, extended duration, short daily or nocturnal home HD therapy, known
as High Dose HD therapy^1.

Baxter's VIVIA hemodialysis (HD) system is designed to treat end stage renal
disease patients by del ...

Baxter's VIVIA hemodialysis (HD) system is designed to treat end stage renal
disease patients by delivering more frequent, extended duration, short daily
or nocturnal home HD therapy, known as High Dose HD therapy. The system's
touch screen and graphic user interface displays large, easy-to-comprehend
graphics and animations that help guide patients through setup, treatment and
cleanup. Among its features is a fully integrated wireless connectivity
platform that allows healthcare providers to monitor their patients remotely.
(Photo: Business Wire)

''Globally, less than 1 percent of the estimated 1.9 million patients
requiring hemodialysis currently perform High Dose HD therapy,'' said Bruce
Culleton, M.D., senior medical director, Baxter. ''VIVIA will allow a greater
number of hemodialysis patients access to High Dose HD therapy in their home
environment.''

VIVIA is designed with the patient as the primary operator. Its touch screen
and graphic user interface displays large, easy-to-comprehend graphics and
animations that help guide patients through setup, treatment and cleanup^2.
VIVIA’s Access Disconnect Sensor causes the system to stop pumping if the
needle dislodges^1,2. The system also has one-button fluid infusion to help
minimize user error and promote additional safety for the patient^1. To
support the important interface between patients and their healthcare
practitioners, VIVIA includes the fully integrated Sharesource wireless
connectivity platform that allows physicians and nurses to comprehensively
monitor home therapy remotely^1.

Baxter will introduce VIVIA in a limited number of European dialysis clinics
in 2014 to allow patients and healthcare providers to become familiar with the
system and its patient-friendly features. Baxter plans to expand the launch to
other European countries in 2015.

Data from clinical trials conducted in the United States and Canada evaluating
the safety and effectiveness of VIVIA in more than 1,000 treatments were
submitted as part of the filing for CE marking^1,3. ^ CE mark is a regulatory
requirement for medical devices to be sold in the European Union.

''At Baxter, we are committed to providing physicians and their patients with
product and therapy options for the best clinical outcomes possible,'' said
Brik Eyre, president of Baxter’s Renal business. ''The VIVIA system was
developed to support renal patients’ unmet need for an innovative home-based
hemodialysis option.''

Rx only. For safe and proper use of this device, refer to the complete
instructions in the operator's manual.

High Dose HD

An estimated 1.9 million end-stage kidney disease (ESKD) patients worldwide
undergo hemodialysis, with the vast majority receiving conventional
hemodialysis (CHD), which is usually performed three times a week for three to
five hours per session in a center or clinic^4.

High Dose HD therapy is a more frequent therapy usually performed as short
daily treatments at least five days per week for sessions that typically run
less than four hours, or as nocturnal treatments where sessions are conducted
for greater than six hours while the patient sleeps^5. High Dose HD therapy is
associated with improvements in survival and clinically important health
measures, including health-related quality of life, compared with CHD^6,7,8,9.

About Baxter International Inc.

Baxter International Inc., through its subsidiaries, develops, manufactures
and markets products that save and sustain the lives of people with
hemophilia, immune disorders, infectiousdiseases, kidney disease, trauma and
other chronic and acute medical conditions. As aglobal, diversified
healthcare company, Baxter applies a unique combination of expertise in
medical devices, pharmaceuticals and biotechnology to create products that
advance patient careworldwide.

This release includes forward-looking statements concerning VIVIA, Baxter’s
home hemodialysis system, including expectations regarding the planned launch
of VIVIA in Europe and its potential impact on patients.The statements are
based on assumptions about many important factors, including the following,
which could cause actual results to differ materially from those in the
forward-looking statements:actions of regulatory bodies and other
governmental authorities; satisfaction of regulatory and other requirements;
product quality or patient safety issues; changes in laws and regulations; and
other risks identified in Baxter’s most recent filing on Form 10-K and other
SEC filings, all of which are available on Baxter’s website. Baxter does not
undertake to update its forward-looking statements.

^1 Data on file, Baxter International Inc., Oct. 1, 2013

^2 Data on file, Baxter International Inc., June 27, 2012

^3 Data on file, Baxter International Inc., May 16, 2013

^4 Fresenius Medical Care: ESRD Patients in 2011, A Global Perspective.
Available at
http://www.vision-fmc.com/files/download/ESRD/ESRD_Patients_in_2011.pdf.
Accessed September 4, 2013.

^5 Data on file, Baxter International Inc., November 8, 2013

^6 Pauly RP, Gill JS, Rose CL, et al. Survival among nocturnal home
haemodialysis patients compared to kidney transplant recipients. Nephrol Dial
Transplant. 2009;24(9):2915-2919.

^7 Chertow GM, Levin NW, Beck GJ; FHN Trial Group. In-center hemodialysis six
times per week versus three times per week. N Engl J Med.
2010;363(24):2287-2300.

^8 Nesrallah GE, Lindsay RM, Cuerden MS, et al. Intensive hemodialysis
associates with improved survival compared with conventional hemodialysis. J
AM Soc Neprol. In press.

^9 Culleton B, et al. Effect of frequent nocturnal hemodialysis vs
conventional hemodialysis on left ventricular mass and quality of life. JAMA
2007; 298 (11) 1291-1299.

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Contact:

Baxter International Inc.
Media Contacts:
Jill Carey-Hargrave
or Bill Rader
(224) 948-5353
media@baxter.com
or
Investor Contacts:
Mary Kay Ladone
(224) 948-3371
or
Clare Trachtman
(224) 948-3085
 
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