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Home » Fresenius wins FDA approval for next-gen dialysis solution bags

Fresenius wins FDA approval for next-gen dialysis solution bags

October 22, 2020 By Chris Newmarker

Fresenius Medical CareFresenius Medical Care North America (NYSE:FMS) recently announced that FDA has approved its Deleflex peritoneal dialysis solutions bagged in its less wasteful Biofine material.

Company officials expect the new Biofine peritoneal solutions bag to be first available to a limited number of patients in the U.S. this fall.

“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.

“We are excited to bring this innovative new product, which aims to make home treatment even easier, to market,” Costanzo said in an Oct. 19 news release.

FMCNA said Biofine advantages include:

  • The new manufacturing line offers additional capacity to support the growing U.S. patient population engaging in dialysis at home.
  • There’s a user-friendly design for easy storage and use.
  • Biofine material generates less waste and is PVC-free.

The Biofine bags are 60% thinner than alternative materials, which saves raw materials and reduces waste. Plus, Biofine degrades upon incineration with no release of hydrochloric acid. It eliminates DEHP plasticizers.

“We are pleased to ramp up the production and distribution of Biofine in our plant and new distribution center in Knoxville, Tenn.,” said Kent Wanzek, CEO of Global Manufacturing, Quality & Supply at Fresenius Medical Care. “This extends and further leverages our global production and distribution footprint, providing a reliable supply of solutions to home patients worldwide.”

Filed Under: Dialysis, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Fresenius Medical Care

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About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at [email protected].

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