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BAXTER
RECEIVES FDA CLEARANCE FOR AUTOMATED BLOOD COMPONENT COLLECTION SYSTEM
Baxter's ALYX System
Assists Blood Centers in Increasing the Blood Supply from Existing Donor
Pool
New System Offers
Fast, Easy Way to Collect and Process Blood Components
DEERFIELD, Ill., September
12, 2002 -- Baxter Healthcare Corporation received clearance from the
U.S. Food and Drug Administration (FDA) for a fast, portable, automated
blood collection system that offers the potential to increase the supply
of vitally needed blood components. The ALYX Component Collection System
allows blood centers to collect two units of red blood cells, instead
of just one, from eligible donors. It is expected to be available to U.
S. blood centers by the end of this year.
Red blood cells are primarily collected through manual whole blood donations.
Each unit of whole blood is separated into components, producing a single
transfusion dose of red blood cells. The ALYX System can collect two transfusion
doses of red blood cells from a single donor through a fast, automated
process that retains only the desired blood component and returns the
remaining blood components and saline to the donor in an average of just
22 minutes.
"The ALYX System comes at a critical time as the demand for red blood
cells is increasing" said Charles Mosher, president and chief executive
officer of BCA/hemerica, a cooperative providing services to 29 member
blood centers across the country. "It will enable us to collect more
red blood cells from our current donor base."
Addressing the blood supply shortage
Each year approximately 14 million units of red blood cells are collected
in the United States for transfusion to patients in need, including people
undergoing surgery and accident victims. This summer, nearly one-half
of American Red Cross Blood Services regions and one-third of America's
Blood Centers member organizations were suffering from shortages1.
According to blood bank and public health officials, increasing restrictions
on donors and a general misperception about the need for donors have been
key factors contributing to the shortage of donors. As critical as the
situation now appears, it is expected to worsen with the aging population
and an increase in the number of elective surgeries requiring blood transfusions.
"By providing a fast, integrated approach to collecting more red
blood cells from fewer donors, we hope to help make high quality, critical
blood components more available to patients in need," said Dr. Dean
Elfath, vice president, medical and clinical affairs for Baxter's Fenwal
business.
Automation provides greater efficiencies, mobility supports increased
supply
The ALYX system allows for more efficient processing of blood components
over manual methods by combining collection, component separation and
leukoreduction, into a single, integrated process. It is the first two-unit
blood collection system to offer an integrated leukoreduction process,
which removes white blood cells from blood components. White blood cells
have been associated with the transmission of certain infectious diseases
and the development of immune reactions in transfusion recipients.
Through integrated collection and processing, the ALYX System reduces
the number of manual steps required, decreasing the potential for error
and reducing demands on limited blood center resources. The ALYX System
has been shown in clinical studies to consistently deliver standardized,
high-quality blood components.
The compact size of the ALYX System, which folds up to about the size
of a standard suitcase, will allow blood centers to use it in a number
of settings, including mobile blood drives at offices, schools, churches
and community centers. This is expected to help further increase the availability
of the blood supply, since the majority of whole blood collections take
place in a mobile setting.
The FDA clearance of the ALYX System for the collection of two units of
leukoreduced red blood cells from a single donor is the first of several
protocols being developed for the device. Additional protocols are under
development to enable the collection and processing of plasma and a combination
of a single unit of red blood cells and two units of plasma.
Because donors on the ALYX System are giving two units of red blood cells
instead of one, the donor criteria is slightly more restrictive. The current
indication is for male donors with a minimum height of 5 feet, 1 inch,
minimum weight of 130 pounds and a hematocrit (red blood cell content
of whole blood) of at least 40 percent. Baxter is collecting additional
data to expand the indication to female donors.
To learn more about donating blood or to request an appointment to donate
at your local blood center, visit www.baxterfenwal.com.
Baxter Healthcare
Corporation is the principal domestic operating subsidiary of Baxter International
Inc. (NYSE: BAX), a global health care company that, through its subsidiaries,
provides critical therapies for people with life-threatening conditions.
Baxter's bioscience, medication delivery and renal products and services
are used to treat patients with some of the most challenging medical conditions,
including cancer, hemophilia, immune deficiencies, infectious diseases,
kidney disease and trauma.
NOTE TO MEDIA: To
arrange an interview with a blood center involved in the development of
the ALYX System or a clinical investigator, please call Tanya Tyska at
847-948-3256. Dowload
product photo (hi-res jpeg / lo-res
jpeg)
(Baxter and ALYX are
trademarks of Baxter International Inc.)
This news release
contains forward-looking statements that involve risks and uncertainties,
including technological advances in the medical field, product demand
and market acceptance, the effect of economic conditions, actions of regulatory
bodies, 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
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 Contact:
- Tanya Tyska,
847-948-3256
- Investor Contacts:
- Neville Jeharajah,
Baxter, 847-948-2875
Mary Kay Ladone, Baxter, 847-948-337
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