Baxter International Inc. announced the global launch of HDx enabled by THERANOVA, a new type of hemodialysis (HD) therapy that provides high performance treatments with integration into existing healthcare infrastructure. Baxter will launch HDx enabled by THERANOVA in Australia, New Zealand, France, Germany, Switzerland and Belgium this year.
“Through HDx enabled by THERANOVA, Baxter is introducing a major advancement in hemodialysis, an area that has seen little improvement in recent years,” said Giuseppe Accogli, corporate vice president and president, Baxter Renal. “We expect HDx enabled by THERANOVA to advance hemodialysis care for millions of patients around the world.”
HDx, or expanded hemodialysis, uses Baxter’s new THERANOVA dialyzer to extend the range of molecules that can be filtered from the blood during therapy, resulting in a filtration profile that more closely mimics the natural kidney. THERANOVA dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
Due to kidney failure, people with end-stage renal disease retain harmful molecules in their blood. Hemodialysis therapy is performed to remove those molecules, with the dialyzer acting as the artificial kidney. Current hemodialysis therapies, including conventional HD using a low-flux or high-flux dialyzer and hemodiafiltration (HDF), are effective at removing urea and smaller middle molecules but are limited in removing large middle molecules. Large middle molecules may affect a range of biological functions, including inflammation and cardiovascular risk. The retention of these molecules has also been associated with higher mortality in chronic kidney disease patients.
In a recent study published in Nephrology Dialysis Transplantation, researchers found that THERANOVA removes a wide range of middle molecules more effectively than FX CorDiax, a high-flux dialyzer, and can exceed the performance of high-volume HDF for large solutes, with moderate albumin removal.
In addition to its clearance profile, HDx enabled by THERANOVA is as simple to perform as conventional HD therapy and was designed to work with most HD machines. This allows clinics to offer HDx therapy using existing resources, and eliminates the need for special equipment and added clinic workflow, which is required for HDF. HDF is a type of dialysis therapy that also targets larger middle molecules, but is not as widely available as HD and cannot be performed effectively in all patients.
Baxter previously received regulatory clearance for THERANOVA in Australia, New Zealand, France, Germany, Switzerland and Belgium. THERANOVA is not currently available in the United States.