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Source: Thailand Medical News  Aug 04, 2019  4 years, 6 months, 2 weeks, 3 days, 11 hours, 30 minutes ago

Baxter Gets US FDA Approval For Its PrisMax System For CCRT and TPE

Baxter Gets US FDA Approval For Its PrisMax System For CCRT and TPE
Source: Thailand Medical News  Aug 04, 2019  4 years, 6 months, 2 weeks, 3 days, 11 hours, 30 minutes ago
Baxter International has obtained approval from the US Food and Drug Administration (FDA) for its PrisMax system and integrated TherMax blood warmer, the futuristic platform for continuous renal replacement therapy (CRRT) and therapeutic plasma exchange (TPE) to to treat those with acute kidney injury and certain autoimmune diseases.


The medical device was developed based on inputs and feedback from more than 650 healthcare professionals across the world.
In an exclusive interview with Thailand Medical News, Gavin Cambll, GM of Baxter’s American Renal Division commented “We looked at every detail during the PrisMax designing process. Our team reviewed every piece of input from nephrologists, nurses and intensive care specialists, and then developed a system that can help simplify therapy administration and maximize efficiency. We put two decades of our expertise in continuous renal replacement therapy and blood filtering technology to design an advanced futuristic system that allows for doctors to customize treatment parameters to meet the needs of their patients.”
The PrisMax system will enable to simplify therapy delivery and provides flexibility to the hospitals to meet the unique demands of the ICU. The  system, which is designed based on Baxter’s Prismaflex technology, will be used for the treatment of patients with acute kidney injury (AKI) and select autoimmune diseases.
PrisMax is provided with new digital health features, which enable hospitals to connect the system to electronic medical record (EMR) platforms. It allows direct integration of information from PrisMax to the EMR to help ICU nurses to spend less time manually for the documentation of treatment data and reduce the risk of transcription errors. The system features smart pump settings that guarantee that proper amounts of fluid are removed and that the therapy prescriptions are met.
The system also features TrueVue Analytics, Baxter’s advanced data analytics platform. Hospitals will use TrueVue Analytics tools for review of data aggregated at the hospital level and evaluate the quality and effectiveness of their CRRT programmes.  Additionally, there is  the option to select auto-effluent drain or effluent bag drain configurations.

An international pilot study demonstrated that PrisMax delivered significant improvements in areas that impact efficiency and ease of use, including the time needed for bag changes, the number of informational and malfunction alarms.

Designed to use exclusively with the PrisMax system, the TherMax blood warmer is a major component for extracorporeal CRRT to warm the blood prior to returning to the body, allowing to keep the patient’s body temperature at a normal level. Baxter has introduced PrisMax in over 20 countries across Europe and Australia,  and is planning to submit applications for regulatory approval of the system in additional countries in this year including India, Thailand and Singapore.

For more product info, visit :


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