Baxter International said that the US 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, HHD and Baxter.
HHD owns and licenses certain intellectual property assets expected to be utilised in the home hemodialysis program.
The IDE approval allows the companies to initiate a clinical study in patients undergoing hemodialysis treatment.
DEKA and Baxter expect to begin a clinical study in mid-2011 in the US to assess device performance and safety in patients undergoing hemodialysis.
Twenty-four patients at up to five dialysis centers will each be studied for 10 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 US, 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 US 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.
Baxter International, through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.