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BAXTER
RECEIVES 510(k) APPROVAL FOR EXELTRA, NEW SINGLE-USE DIALYZER FOR KIDNEY
DISEASE
EXELTRA Dialyzer
Provides Higher Clearance to Help Patients Achieve Treatment Goals
DEERFIELD, Ill., May
5, 2003 -- Baxter Healthcare Corporation today announced that it has received
510(k) clearance from the U.S. Food and Drug Administration (FDA) for
the EXELTRA Family of Single-Use Dialyzers, the company's latest single-use
dialyzer to be used by people with kidney disease who are treated with
hemodialysis (HD).
"The clearance of the EXELTRA dialyzer expands Baxter's established
portfolio of hemodialysis products and reaffirms our commitment to continually
advancing hemodialysis treatment," said Alan L. Heller, senior vice
president and president of Baxter's Renal business. "With the introduction
of the EXELTRA dialyzer, we are proud to offer health-care professionals
new tools to provide a more efficient and high-performance hemodialysis
treatment."
This new dialyzer has the thinnest, high-flux membrane available in any
single-use dialyzer. This allows for higher small and middle molecule
clearance of toxins from the blood. The EXELTRA dialyzer family achieves
the highest measurement of solute clearance efficiency (or KoA) per surface
area of all current dialyzers available in North America. Because of its
clearance achievements, the EXELTRA dialyzer family provides the most
efficiency and flexibility in managing treatment times and target dialysis
dose (Kt/V), defined by the National Kidney Foundation K/DOQI treatment
guidelines. Because of its high clearance rate, the EXELTRA Plus 210 dialyzer
also is particularly suitable for hemodialysis patients with larger body
mass, who require greater clearance rates.
The EXELTRA dialyzer membrane is synthesized for clinically-proven biocompatibility,
when compared to standard dialyzers. This process of synthesizing the
membrane, reduces risk factors seen in non-biocompatible membranes, including
inflammatory response and complement activation (the immune system's response
to foreign bodies in the bloodstream). In addition, the EXELTRA dialyzer
is gamma-irradiated (a common dialysis sterilization process involving
gamma radiation) further reducing risks for patients with sensitivity
to ethylene oxide (EtO), a gas frequently used for dialysis sterilization.
The EXELTRA dialyzer capitalizes on an important trend in dialysis treatment
- a movement toward high-flux, single-use dialyzers. Industry experts
believe that single-use dialysis may promote greater patient safety by
reducing the risk of chemicals used to clean reusable dialyzers from entering
a patient's bloodstream. Additionally, single-use dialyzers may require
less technician staff time and expense to prepare dialysis administration
and appropriate cleaning measures required with a reusable dialyzer.
The EXELTRA dialyzer is expected to be available to health-care professionals
in the United States and Canada in the second half of 2003. More information
on Baxter's Renal business can be found at www.baxter.com.
Hemodialysis Background
During hemodialysis, which is one therapy option for end-stage renal disease
patients, blood is removed from the body through a needle inserted into
a blood vessel. The blood is then pumped through a filter, or artificial
kidney, called a dialyzer that cleanses the blood and returns the cleansed
blood back to the body. Hemodialysis also helps to maintain electrolytes
and pH (acid and base balance) at levels that sustain life.
Baxter Background
Baxter's Renal business provides a complete and complementary portfolio
of dialysis-related products used in the treatment of patients with kidney
disease, including dialysis systems and solutions, pharmaceuticals and
biotechnology products.
Baxter Healthcare Corporation is the principal domestic operating subsidiary
of Baxter International Inc. (NYSE: BAX). Baxter International Inc., through
its subsidiaries, assists health-care professionals and their patients
with treatment of complex medical conditions, including cancer, hemophilia,
immune disorders, kidney disease and trauma. The company applies its expertise
in medical devices, pharmaceuticals and biotechnology to make a meaningful
difference in patients' lives.
(BAXTER and EXELTRA
are registered trademarks of Baxter International Inc. and its subsidiaries.)
This news release
contains forward-looking statements that involve risks and uncertainties,
including product demand and market acceptance, the impact of competitive
products and pricing, and other risks detailed in the company's filings
with the Securities and Exchange Commission. These forward-looking statements
are based on estimates and assumptions made by management of the company
and are believed to be reasonable, though are inherently uncertain and
difficult to predict. Actual results or experience could differ materially
from the forward-looking statements.
FOR
ADDITIONAL INFORMATION:
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Media Contacts:
Ilke Arici, Baxter, 847-948-3272
Cindy Resman, Baxter, 847-948-2815
Investor Contacts:
- Neville Jeharajah,
Baxter, 847-948-2875
Mary Kay Ladone, Baxter, 847-948-3371
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