BAXTER'S
HOMECHOICE PEDIATRIC DIALYSIS SYSTEM
RECEIVES MARKET CLEARANCE FROM FDA
Children
With Chronic Kidney Disease Now Have Safe and
Easy-To-Use Home-Based Treatment
DEERFIELD, Ill., December
11, 2001 - Baxter Healthcare Corporation announced today it has received
clearance from the U.S. Food and Drug Administration (FDA) to market its
HomeChoice Pediatric automated peritoneal dialysis (APD) system for use
with pediatric patients undergoing peritoneal dialysis (PD), one form
of dialysis usually performed in the home. HomeChoice Pediatric is designed
to meet the special needs of young patients with end-stage renal disease
(ESRD), an advanced stage of chronic kidney disease that affects more
than 5,000 children and adolescents in the United States. i The HomeChoice
Pediatric dialysis system will be available for use in the United States
in early 2002.
"HomeChoice Pediatric will help me address the unique needs of my
younger patients, offering them a safe and flexible new option for administering
dialysis at home," said Bradley Warady, M.D., director of dialysis
and transplantation and chief of pediatric nephrology at Children's Mercy
Hospital in Kansas City, Mo. "This new technology is easily operated
by parents in the home, and I can remotely monitor my patients' therapy
through innovative software, which tracks patient data and then can be
transmitted to me at work through my computer."
The HomeChoice Pediatric system is portable and easily stored, and has
built-in safety alarms and easy-to-use controls, which set and monitor
fluid levels. In addition, the therapy is performed overnight while the
patient sleeps so interruptions in a child's daytime routine are minimized.
For instance, the therapy does not interfere with a child's school or
day care schedule, and it eliminates the need to travel to a dialysis
center for treatments. ii
The HomeChoice Pediatric system is specifically designed to deliver a
lower volume of fluid to the patient during dialysis-as little as one-quarter
of what adults typically receive-which is required for smaller patients.
The system integrates a new version of Baxter's PD Link software (version
3.0), which enables the physician to remotely monitor the home-based dialysis
therapy. The software is used in conjunction with an electronic data card
or PRO Card, which is inserted into the machine at the start of treatment
and captures information during the dialysis session. The parent can then
share the data with the physician either using a disk or transmitting
through a modem. New software features help to improve patient compliance
as they allow physicians to remotely collect and analyze the data, and
make any necessary prescription adjustments.
Peritoneal dialysis machines, such as HomeChoice Pediatric, utilize a
catheter, surgically implanted in the abdomen or peritoneal cavity, which
serves as the body's natural filter for cleaning out wastes and toxins
from the body-a function that is performed by healthy kidneys. The peritoneal
membrane lines the area that holds the stomach, spleen, liver and intestines.
HomeChoice Pediatric delivers dialysis solution through the catheter to
the peritoneal cavity. Wastes and toxins pass from the bloodstream across
the peritoneal membrane into the dialysis solution. Then, HomeChoice Pediatric
system drains the dialysis solution through the catheter, and this cycle
is repeated until the therapy session is completed.
"This new system for delivering dialysis to younger patients demonstrates
Baxter's continued commitment to improving treatment and care for all
kidney patients," said Alan L. Heller, Baxter senior vice president
and president of its renal business. "I hope this new innovation
will not only help ease some of the burden on parents who care for children
with kidney disease, but also help children enjoy the pleasures of being
children," he added.
Kidney Disease and Peritoneal Dialysis
ESRD leads to the inability of kidneys to effectively fulfill their role
of filtering and removing wastes and toxins from the body. One therapy
for managing this disease is peritoneal dialysis. There are two types
of PD-APD and continuous ambulatory peritoneal dialysis (CAPD). APD is
performed using a machine (cycler), such as HomeChoice Pediatric, for
instillation and drainage of the dialysis solution, and CAPD is performed
using a gravity-based technology instead of the use of a machine.
More than 300,000 people in the United States, or just over one in 1,000
Americans, are being treated for ESRD. And, approximately 1,000 children
develop ESRD each year. iii The number of people being treated for ESRD in
the United States is growing at about seven percent annually. Of the estimated
one million people worldwide suffering from chronic kidney disease who
are treated with some form of dialysis therapy, 10 to 15 percent use PD.
The HomeChoice Pediatric
dialysis system is intended for use only by individuals who require lower
volumes of fluid (less than one liter per exchange). Only a physician
can determine if HomeChoice Pediatric is an appropriate therapy, as PD
is not suitable for all pediatric patients.
Baxter is a leading
provider of renal products and services worldwide. In 1956, the company
introduced the first disposable coil dialyzer, a development that greatly
enhanced the use and application of hemodialysis. Nearly 20 years later,
Baxter was one of the first companies to introduce PD.
Baxter Healthcare Corporation is the principal domestic operating subsidiary
of Baxter International Inc., a global medical products and services company
that, through its subsidiaries, provides critical therapies for people
with life-threatening conditions. Baxter's products and services in bioscience
(biopharmaceuticals, vaccines, biosurgery products and transfusion therapies),
medication delivery and renal therapy are used by health-care providers
and their patients in more than 100 countries.
(HomeChoice
Pediatric, PD Link and PRO Card are trademarks of Baxter
International Inc. and its affiliates.)
_______________________
i U.S. Renal Data System. USRDS 1999 Annual Data Report. Bethesda,
Md: National Institutes of Health, National Institute of Diabetes and
Digestive and Kidney Diseases; 1999.
ii Executive Summaries of the NKF-DOQI Clinical Practice Guidelines,
Section VIII - Suitable Patients for Peritoneal Dialysis, National Kidney
Foundation/DOQI 1997 Web site.
iii Ibid.
FOR ADDITIONAL INFORMATION:
 |
- Media Contacts:
- Diane Foley,
Manning Selvage & Lee, (212) 213-7414
Eric Noshay, Baxter, (847) 948-3202
Tanya Tyska, Baxter, (847) 948-3256
- Investor Contacts:
- Neville Jeharajah,
Baxter, (847) 948-2875
Mary
Kay Ladone, Baxter, (847) 948-3371
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