Nikkiso America Inc. has launched the DBB-06 Hemodialysis System, equipped with a dialysis dose monitor, in the United States.  The U.S. Food and Drug Administration gave the device 510(k) clearance in March. This launch marks the entrance into the U.S. renal market for Nikkiso Medical. The company is the second largest producer of hemodialysis equipment globally with over 100,000 hemodialysis machines in clinical use.

“After achieving a strong position in the global markets due to our outstanding product reliability, we are now providing a new option in hemodialysis equipment for U.S. clinics,” said Thomas Kelly, president of Nikkiso America’s Medical Division. “Nikkiso America is committed to continuing our company’s legacy of innovation to improve hemodialysis treatment outcomes while also addressing the needs of the care team.”

The system includes a blood volume monitor, designed to help the clinician evaluate and react to the patient’s hydration status by continuously monitoring relative blood volume during treatment. The DBB-06 Hemodialysis System with DDM also includes:

  • Features such as ultrafiltration profiling, ultrapure dialysate, patient blood pressure monitoring
  • A touchscreen user interface and the storage and recall of up to 16 patient prescriptions
  • Enhanced automation, with programmed self-test/extracorporeal circuit priming and automatic disinfection and decalcification
  • Data connection to the electronic medical record
  • The Dialysis Dose Monitor to assist the care provider in real-time to ensure an adequate treatment for the patient
  • Safety features, including a battery backup system in the case of power failure and continuous monitoring of the fluid removal system