Baxter International Inc. (NYSE:BAX) announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for a Home Hemodialysis (HD) system in development through a collaboration between DEKA Research and Development Corp., HHD LLC, and Baxter. The IDE approval allows the companies to initiate a clinical study in patients undergoing hemodialysis treatment.
"This regulatory milestone is an important step in our efforts to advance the care of patients with end-stage renal disease," said Carlos Alonso, president of Baxter's global Renal business.
"We are gratified to achieve this milestone in support of this new Home Hemodialysis device," said Dean Kamen, founder of DEKA.
DEKA and Baxter expect to begin a clinical study in mid-2011 in the U.S. to assess device performance and safety in patients undergoing hemodialysis. Twenty-four patients at up to five dialysis centers will each be studied for ten weeks. The study will take approximately six months to complete. Successful completion of this study will allow DEKA and Baxter to continue on the pathway towards regulatory approval in the U.S., which will likely include additional clinical studies in dialysis patients and may support an indication for nocturnal hemodialysis. The companies expect to seek regulatory approval of the Home Hemodialysis system in the U.S. in 2013.
An additional study, scheduled to begin in 2011 in Canada, will focus on device performance and safety in a nocturnal setting. Successful completion of this study will support regulatory approval in Europe, which is expected in 2012.
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