Baxter Healthcare Corporation has received 510K clearance from the U.S. Food and Drug Administration (FDA) to market ARENA, a new hemodialysis (HD) device that offers a broad range of features to assist health-care professionals administer therapies to end-stage renal disease (ESRD) patients through a more user-friendly design. Arena's enhanced design may reduce clinician staff time for set up, administration and monitoring of hemodialysis treatment.
"With increasing pressure generated by the multiple activities required to deliver quality care to hemodialysis patients, patient safety and treatment flexibility are increasingly important. Arena's broad range of ease-of-use features with its advanced ergonomic design should simplify the delivery of a dialysis prescription," said William Owen, Jr., chief scientist, Baxter's Renal business.
Baxter designed the ARENA device in response to extensive customer feedback. It includes many enhancements and applications important to both kidney dialysis patients and health-care providers, for example: a large color touch screen for easier data entry that can be viewed from a distance, a sodium button that simplifies the delivery of a boost of saline used to combat cramping (a side effect of dialysis treatment) and a pre-programmable patient data card containing a patient's individual prescription for dialysis, ensuring accurate prescription entry and reducing staff time for set up that would be required with other dialysis machines. These features allow for greater patient and dialysis administrator convenience by cutting down time of treatment and allowing for greater control of the dialysis device.
"The development and marketing clearance of ARENA reaffirms our continued focus on hemodialysis treatment," added Alan L. Heller, senior vice president and president of Baxter's Renal business. "Consolidating the best features from different technology platforms and providing a user-friendly and more sophisticated delivery of treatment will be the cornerstone of our hemodialysis business. We expect that ARENA and other new products in our pipeline will enhance the Renal business' portfolio."
ARENA will be used to treat patients with ESRD, an advanced stage of chronic kidney disease that affects more than 300,000 people in the United States. It will be sold to public and private dialysis centers and will be available in the United States and select European countries later this year.