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. 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.
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. 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.)
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.
Executive Summaries of the NKF-DOQI Clinical Practice Guidelines, Section VIII – Suitable Patients for Peritoneal Dialysis, National Kidney Foundation/DOQI 1997 Web site. Ibid.
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