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News Release

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:

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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