Baxter nets FDA de novo clearance for a new class of dialysis filter, closer to the human kidney

Baxter has received a green light from the FDA for a new type of dialysis filter that sifts out a wider range of molecules from the blood compared to traditional membranes—including those associated with the heightened inflammatory and cardiovascular disease seen in patients suffering from kidney failure.

The Theranova cartridge is designed to be used with existing dialysis machines with little change in treatment, while offering a filtration profile that more closely mimics the natural kidney, the company said.

"Individually, the side effects from standard [hemodialysis], which patients typically undertake three days a week, four hours per day, may seem manageable,” said Mary Gellens, senior medical director at Baxter. “However, the chronic effects of treatment accumulate and over time, cause some patients to give up on therapy."

The Theranova dialyzer (Baxter)

The expanded hemodialysis therapy provided by Theranova clears out a group of larger, heavier chains of molecules that form uremic toxins, which are typically removed from the body through well-functioning kidneys. 

The dialyzer also allows the blood’s essential proteins to pass back into the patient and helps to maintain proper levels of albumin, which carry hormones and enzymes throughout the body.

Theranova was previously launched outside of the U.S. in 2016, and is currently available in 44 countries. The FDA granted Baxter a de novo clearance, a rarity for kidney failure treatments, establishing a new regulatory class of dialyzer.