The Food and Drug Administration has approved DELFLEX peritoneal dialysis solutions in Biofine, an innovative bag material made by Fresenius Medical Care North America’s Renal Therapies Group.
Fresenius is aiming to grow home dialysis, including dialysis care provided in skilled nursing homes, through new and improved products.
“The new Biofine peritoneal dialysis solutions line is part of our ongoing commitment to expand supply of peritoneal dialysis solutions and make home dialysis available to more patients with kidney failure,” said Mark Costanzo, president of FMCNA’s Renal Therapies Group.
The Biofine line offers three key advantages for peritoneal dialysis patients and the clinicians who manage their care:
Additional capacity to support patient growth: For physicians and clinicians interested in encouraging more patients to do their dialysis therapy at home, the new manufacturing line offers additional capacity to support the growing patient population.
Built-in convenience for patients: User-friendly design for easy storage and use.
Environmentally friendly: Biofine material generates less waste and is PVC-free to address growing environmental concerns. A bag is up to 60 % thinner than alternative materials, saving raw materials and reducing waste. Biofine also degrades upon incineration with no release of hydrochloric acid and eliminates DEHP plasticizers.
“After transplantation, home therapy has repeatedly been demonstrated as the preferred alternative for many end stage renal disease patients and the healthcare system,” said Dr. Mike Anger, M.D., chief medical officer for FMCNA’s Renal Therapies Group. “This expansion of Fresenius Medical Care’s capacity with an innovative new product marks another step toward improving the quality of life for dialysis patients.”
The new Biofine peritoneal solutions bag is expected to be first available to a limited number of patients in the U.S. this fall.
