2008® Series Hemodialysis Machine with New Tubing Released for Care Delivery
FDA cleared deployment of platinum catalyst tubing with no detectable PCBAs for all new 2008 Series HD machines from Fresenius Medical Care North America
WALTHAM, Mass., Dec. 19, 2022 /PRNewswire/ -- Fresenius Medical Care North America’s (FMCNA) Renal Therapies Group, a leading provider of products and services for people with chronic kidney failure, announced that the U.S. Food and Drug Administration (FDA) has cleared the 2008 Series hemodialysis machine with platinum catalyst silicone tubing.
The platinum catalyst tubing eliminates detectable non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) in 2008 Series machines. This new tubing addresses concerns raised in May 2022.
Dr. Michael Anger, Chief Medical Officer of FMCNA’s Renal Therapies Group said, “A top priority for Fresenius Medical Care is to provide the very best and safest dialysis equipment available. The modified tubing is another example of our commitment to helping our customers provide the highest quality of care to their patients possible. We appreciate them for their patience and continued patronage.”
All new 2008T hemodialysis machines shipped since October 27, 2022, use platinum catalyst tubing. Orders are being prioritized based on availability and the date the order was placed.
Pat McCarthy, Senior Vice President of FMCNA’s Renal Therapies Group, emphasized, “During these challenging times, we are grateful to our customers for their trust, and to our employees for their extraordinary efforts in the successful development of modified tubing with no detectable PCBAs.”
For any questions or inquiries regarding silicone tubing in the hydraulics of your 2008T hemodialysis machines, please contact FMCNA’s Medical Information Office at firstname.lastname@example.org or 1-855-616-2309.
INDICATIONS FOR USE
2008T BlueStar™ Hemodialysis Machine: The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.
Additional therapy options for patients receiving hemodialysis include Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low-volume hemodialysis (patients weighing ≥ 20 kg and ≤ 40 kg). This machine accommodates the use of both low- and high-flux dialyzers. The SLED therapy option is not to be used for plasma replacement therapies, for patients weighing ≤40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.
CAUTION: Federal (U.S.) law restricts this device to sale only by or on the order of a physician. Frequency, duration, and parameters of treatment are to be determined by the prescribing physician.
NOTE: Not all features are available in all regions.
About Fresenius Medical Care North America
Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities and outpatient cardiac and vascular labs, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com/.
Fresenius Medical Care North America
Scott Sayres, Corporate Communications
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. Kagan does not undertake any responsibility to update the forward-looking statements in this release.
© 2022 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, 2008, and 2008T BlueStar are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. P/N 105385-01 Rev A 12/2022
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SOURCE Fresenius Medical Care Holdings, Inc.