Baxter International has received the US Food and Drug Administration (FDA) De Novo authorisation for its new dialysis membrane Theranova.
Theranova is designed to deliver expanded hemodialysis (HDx) therapy. The process involves filtering a wider range of molecules from the blood by targeting the effective removal of conventional and large middle molecules.
HDx is carried out the same way as conventional HD with only a change of the dialyser membrane.
Theranova’s medium cut-off membrane combines high permeability and selectivity for uremic toxins while retaining essential proteins and maintaining albumin levels during treatment.
The cut-off and high retention onset profile accelerate clearance, offering filtration closer to that of the natural kidney, the company noted.
Fewer than 1% of devices have been granted marketing authorisation by the agency under De Novo for the care of patients with kidney failure.
Baxter US Renal Care business general manager Gavin Campbell said: “US patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova.
“Patients are currently treated with HDx enabled by Theranova in more than 40 countries worldwide, and we are doing everything we can in the US to ensure healthcare providers can also realise the full value of this therapy for their patients on HD.”
According to the company, there have been over 90 independent and Baxter-led or sponsored studies on HDx therapy enabled by Theranova.
The studies evaluated a range of clinical and quality-of-life measures, including the ability to clear conventional and large middle molecules, albumin retention, chronic inflammation and other side effects of standard HD therapy.
In addition, the company conducted a randomised controlled clinical study in the US to evaluate the safety and efficacy of HDx therapy enabled by Theranova.
It found that expanded hemodialysis therapy with the Theranova 400 dialyser enables superior removal of large middle molecules compared to a similarly sized high flux dialyser while maintaining serum albumin levels.
Theranova is currently available in 44 countries across Europe, Latin America, Asia and in Canada, and is used in over 850 clinics globally.