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. 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 childs daytime routine are minimized. For instance, the therapy does not interfere with a childs 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 dialysisas little as one-quarter of what adults typically recei

Contact: Diane Foley
Manning Selvage & Lee

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