Baxter gets FDA De Novo authorisation for Theranova dialyser
Baxter International has secured De Novo authorisation from the US Food and Drug Administration (FDA) for its Theranova dialysis membrane.
The company has developed Theranova dialyser for the delivery of expanded hemodialysis (HDx) therapy that facilitates to filter a range of molecules from the blood.
According to the company, the FDA is establishing a new class of dialyser technology with advanced performance standards by granting a De Novo application.
Designed to work more efficiently than traditional hemodialysis (HD) filters such as high-flux membranes, Theranova enables efficient removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa).
The middle molecules may be linked with inflammation and cardiovascular disease in patients with kidney failure.
Theranova features an advanced Medium Cut-Off membrane that helps to retain essential proteins
Theranova features an advanced Medium Cut-Off membrane that combines high permeability and selectivity for uremic toxins. Its membrane also helps to retain essential proteins and maintain albumin levels during treatment.
More than 90 independent and Baxter-led or sponsored studies were carried out on HDx therapy enabled by Theranova, to date.
The studies assessed a range of clinical and quality-of-life measures, including the capacity to clear conventional and large middle molecules, albumin retention, chronic inflammation and other side effects of standard HD therapy.
Theranova, which was launched outside of the US in 2016, is presently available in 44 countries across Europe, Latin America, Asia, and Canada. It is said to be used in more than 850 clinics across the globe.
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 realize the full value of this therapy for their patients on HD.”
Recently, Baxter secured emergency use authorisation from the FDA for Regiocit, a replacement solution for patients suffering from acute kidney injury (AKI).