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BAXTER
RECEIVES 510K CLEARANCE FROM U.S. FDA FOR ARENA, AN INNOVATIVE HEMODIALYSIS
DEVICE
ARENA's Advanced
Technology Simplifies the Delivery of Sophisticated Hemodialysis Therapies
and Provides More Flexible Care for Kidney Disease Patients
DEERFIELD, Ill., June
24, 2003 -- Baxter Healthcare Corporation announced today that it has
received 510K clearance from the U.S. Food and Drug Administration (FDA)
to market ARENA, a new hemodialysis (HD) device that offers a broad range
of features to assist health-care professionals administer therapies to
end-stage renal disease (ESRD) patients through a more user-friendly design.
Arena's enhanced design may reduce clinician staff time for set up, administration
and monitoring of hemodialysis treatment.
"With increasing
pressure generated by the multiple activities required to deliver quality
care to hemodialysis patients, patient safety and treatment flexibility
are increasingly important. Arena's broad range of ease-of-use features
with its advanced ergonomic design should simplify the delivery of a dialysis
prescription," said William Owen, Jr., M.D., chief scientist, Baxter's
Renal business.
Baxter designed the ARENA device in response to extensive customer feedback.
It includes many enhancements and applications important to both kidney
dialysis patients and health-care providers, for example: a large color
touch screen for easier data entry that can be viewed from a distance,
a sodium button that simplifies the delivery of a boost of saline used
to combat cramping (a side effect of dialysis treatment) and a pre-programmable
patient data card containing a patient's individual prescription for dialysis,
ensuring accurate prescription entry and reducing staff time for set up
that would be required with other dialysis machines. These features allow
for greater patient and dialysis administrator convenience by cutting
down time of treatment and allowing for greater control of the dialysis
device.
"The development and marketing clearance of ARENA reaffirms our continued
focus on hemodialysis treatment," added Alan L. Heller, senior vice
president and president of Baxter's Renal business. "Consolidating
the best features from different technology platforms and providing a
user-friendly and more sophisticated delivery of treatment will be the
cornerstone of our hemodialysis business. We expect that ARENA and other
new products in our pipeline will enhance the Renal business' portfolio."
ARENA will be used to treat patients with ESRD, an advanced stage of chronic
kidney disease that affects more than 300,000 people in the United States.
It will be sold to public and private dialysis centers and will be available
in the United States and select European countries later this year.
Kidney Disease and Hemodialysis
In chronic kidney disease, the kidneys are irreversibly destroyed by disease
and can no longer effectively fulfill their role of filtering and removing
wastes, toxins and fluid from the body. During HD, which is one therapy
for managing this disease, blood is removed from the body through a needle
inserted into a blood vessel. The blood is then pumped through a machine
containing a filtering system called a dialyzer that cleanses the blood
and returns the cleansed blood back to the body.
Most HD patients receive treatment at a special center and typically require
four-hour dialysis sessions three times a week. A trained health-care
professional handles the administration of therapy during in-center sessions.
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.
ARENA and Baxter are
registered trademarks of Baxter International Inc. and its affiliates.
FOR ADDITIONAL
INFORMATION:
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For Baxter
- Media Contacts:
- Ilke Arici,
847-948-3272
- Investor Contacts:
- Neville Jeharajah,
847-948-2875
Mary Kay Ladone, 847-948-3371
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