FDA Approves New Container System for Peritoneal Dialysis Solutions

Fresenius Medical Care North America's (FMCNA) Renal Therapies Group announced today that DELFLEX® peritoneal dialysis solutions in Biofine®, an innovative bag material, has been approved by the U.S. Food and Drug Administration (FDA). The milestone marks another important step in the company's commitment to grow home dialysis through new and improved products.

Mark Costanzo, President of FMCNA's Renal Therapies Group Said: "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, We are excited to bring this innovative new product, which aims to make home treatment even easier, to market."

The Biofine line of products offers three key advantages for peritoneal dialysis (PD) 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, in line with the objectives of last year's Executive Order on Advancing American Kidney Health.
  • 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 the growing concerns about preserving our environment.

The Biofine bag material is already used by thousands of Fresenius Medical Care patients around the world. This product also demonstrates the company's commitment to sustainability, offering a bag that is up to 60 percent thinner than alternative materials, saving raw materials and reducing waste. Additionally, Biofine degrades upon incineration with no release of hydrochloric acid and eliminates DEHP plasticizers.

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

Dr. Mike Anger, Chief Medical Officer for FMCNA's Renal Therapies Group Said: "After transplantation, home therapy has repeatedly been demonstrated as the preferred alternative for many end stage renal disease patients and the healthcare system, 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. 

INDICATIONS AND USAGE

DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.

IMPORTANT SAFETY INFORMATION

  • Intended for intraperitoneal administration only;
  • Not for intravenous or intra-arterial administration;
  • Use aseptic technique throughout the procedure;
  • Monitor routinely for electrolyte, fluid, and nutrition imbalances;
  • Monitor for signs of peritonitis or overfill;
  • Inspect the drained fluid for fibrin or cloudiness;
  • Ensure that there is no leakage around the catheter;
  • Solution-related adverse reactions may include peritonitis, catheter site infection, electrolyte and fluid imbalances, hypovolemia, hypervolemia, hypertension, disequilibrium syndrome, muscle cramping, abdominal pain, abdominal distension, and abdominal discomfort.

DELFLEX is available by prescription only. For additional Safety Information, please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188. You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088

SOURCE Fresenius Medical Care Holdings, Inc.

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