Baxter (NYSE:BAX) announced today that it received FDA De Novo classification for its Theranova novel dialysis membrane.
Theranova is designed to deliver expanded hemodialysis (HDx) therapy, filtering a wider range of molecules from the blood than traditional hemodialysis (HD) filters, targeting certain molecules associated with inflammation and cardiovascular disease in patients with kidney failure, according to a news release.
HDx is similar to conventional HD, but has a change of the dialyzer membrane, allowing the Theranova’s “medium cut-off” membrane to combine high permeability and selectivity for uremic toxins while retaining essential proteins and maintaining albumin levels during treatment.
Deerfield, Ill.-based Baxter conducted a randomized, controlled study of Theranova in the U.S., evaluating safety and efficacy. After observing 172 hemodialysis patients who received therapy through either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (ELISIO-17H) over 24 weeks, it found that therapy with the Theranova 400 provides superior removal of large middle molecules believed to contribute to the high cardiovascular disease burden in end-stage kidney disease.
“U.S. patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova,” GM of Baxter’s U.S. renal care segment Gavin Campbell said in the release. “Patients are currently treated with HDx enabled by Theranova in more than 40 countries worldwide, and we are doing everything we can in the U.S. to ensure healthcare providers can also realize the full value of this therapy for their patients on HD.”