FDA approves new container system for peritoneal dialysis solutions
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The FDA has approved Fresenius Medical Care North America’s Delflex peritoneal dialysis solutions in Biofine, a new bag material that is more efficient and environmentally friendly, according to a press release.
“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,” Mark Costanzo, renal therapies group president of Fresenius Medical Care North America, said in the release. “We are excited to bring this innovative new product, which aims to make home treatment even easier, to market.”
Costanzo said the new solutions offer additional capacity for patients on PD and the Biofine bag has a user-friendly design for easier storage and use. Biofine material generates less waste and is PVC-free, according to the release.
The bag is up to 60% thinner than alternative materials, according to the release, which saves raw materials and reduces waste. Biofine also degrades upon incineration with no release of hydrochloric acid and eliminates di(2-ethylhexyl)phthalate DEHP plasticizers, the company said.
“After transplantation, home therapy has repeatedly been demonstrated as the preferred alternative for many end-stage renal disease patients and the health care system,” Mike Anger, MD, chief medical officer for the renal therapies group, said. “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.”
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