A growing number of patients in Europe and Asia are receiving a new form of renal replacement therapy called hemodiafiltration instead of hemodialysis. In fact, about one-third of patients in Europe currently receive hemodiafiltration, and that number is growing by about 6% a year, according to Bernard Canaud, MD, chief medical scientist at Fresenius Medical Care in Germany.
Hemodiafiltration’s growing popularity abroad is being driven in part by European studies suggesting that the newer technique leaves patients feeling better with less fatigue and fewer cramps and because of emerging data suggesting that it may also offer cardiovascular benefits, Canaud explained.
Until recently, the U.S. Food and Drug Administration (FDA) had not approved any hemodiafiltration devices, so it hasn’t been an option for patients in the United States. But the Kidney Health Initiative (KHI), a public–private partnership that includes the American Society of Nephrology, the FDA, makers of hemodiafiltration equipment, and other stakeholders have been working to change that.
KHI aims to stimulate innovation and research on kidney diseases, and the treatment of kidney diseases has been one area that has lagged behind in terms of research and new treatment options, said Stephen Ash, MD, a member of the KHI hemodiafiltration work group and medical director at Hemocleanse, Inc. Dialysis.
KHI has brought together nephrologists, regulators, patients, and companies to try to identify and overcome challenges that stand in the way. One of the biggest hurdles to bringing hemodiafiltration to the United States has been that there wasn’t a clear pathway for companies to gain clearance from the FDA for marketing hemodiafiltration devices.
“That was the biggest impediment to the improvements in that area,” Ash said.