Fresenius Medical Care North America Launches 2008T BlueStar™ Hemodialysis Machine Across the U.S.

FRESENIUS MEDICAL CARE NORTH AMERICA ADVANCES RENAL CARE WITH NEXT GENERATION DIALYSIS DELIVERY SYSTEM FEATURING MORE THAN 30 ENHANCEMENTS

WALTHAM, MASS. – Feb. 11, 2019 – Fresenius Medical Care North America’s Renal Therapies Group today announced market availability of the 2008T BlueStar™ hemodialysis machine. With evolved technologies and elevated performance across more than 30 unique enhancements, the 2008T BlueStar machine represents the most comprehensive upgrade in company history. The 2008T BlueStar machine is designed to provide simpler operation and maintenance with greater user control, leading to potential labor and cost savings, improved accuracy, an enhanced data stream and additional treatment options.

The 2008T BlueStar machine features various automated technologies, including automated start and priming mechanisms, assisted reinfusion and reduced dialysate and water usage via idle mode, all of which help simplify machine operation, management and maintenance. Additional enhancements such as reduced preventive machine maintenance provide significant operational savings for health systems.

“The new and enhanced 2008T BlueStar hemodialysis machines provide more than 30 unique enhancements to better serve end stage renal disease patients undergoing dialysis,” said Mark Costanzo, President of Renal Therapies Group at Fresenius Medical Care North America. “Our new machines represent a significant step forward for providers and patients who depend upon our life-sustaining technologies and an exciting continuation of our 30-year commitment to the treatment of end stage renal disease.”

Enhancements of the 2008T BlueStar machine include:

• Auto Start: Performs most self-tests automatically after Auto Prime is completed, including the four tests that require the bloodline to be connected and primed.
• Auto Prime: Requires fewer steps and user touches than current priming methods and primes the dialysate side of the dialyzer first, resulting in less air in the dialyzer.
• Assisted Reinfusion: Automates the reinfusion process by using the venous blood detector to detect end of blood return.
• Idle Mode: Reduces dialysate and water usage by up to two-thirds, with accompanying cost savings.
• Independent Conductivity and pH Self-Test: Uses the post-dialyzer conductivity cell as an independent conductivity check and checks the pH automatically when the machine is using an optional bibag® on-line dry bicarbonate concentrate.
• Disinfection Log: Provides quick access to a log of the last 1,200 disinfection events and downloads the log to a USB drive or the Medical Information System (MIS).
• PatientCards (optional): The 2008T BlueStar technology enables the download of prescription parameters from the PatientCard or MIS, potentially reducing the risk for input error.
• Low Volume Therapy: Enables treatment of patients weighing ≥ 20 kg and ≤ 40 kg.
• Sustained Low Efficiency Dialysis (SLED): Allows acute patients to be dialyzed continuously over a longer period of time — up to 12 hours.
• Enhanced Crit-Line® Treatment Data: Facilitates simplified and improved reporting and analysis when using the optional CLiC™ device.

“Leveraging our history of innovation and industry firsts in renal care, we are pleased to unveil new features that will help providers deliver the highest quality of care to patients receiving hemodialysis both in-center and in the acute care setting,” said Dr. Robert Kossmann, Chief Medical Officer for Renal Therapies Group at Fresenius Medical Care North America. “We believe our 2008T BlueStar machine offers distinct clinical advantages that streamline the complexities of hemodialysis care and enhance patients’ overall treatment experience.”

Through the addition of new parts and updated software, all enhancements are available for existing 2008T hemodialysis machines through an upgrade process.

For more information about 2008T BlueStar hemodialysis machine, please click here.

INDICATIONS FOR USE

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 patients weighing ≤40 kg. The 2008T and 2008T BlueStar hemodialysis machines are 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: Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects and precautions, see full package labeling at fmcna.com.

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, outpatient cardiac and vascular labs and urgent care centers, 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.