FDA OKs Baxter’s Next-Gen Renal Replacement Therapy & Plasma Exchange Device

Baxter International Inc. announced 510(k) clearance of the PrisMax system and integrated TherMax blood warmer, the company’s next-generation platform for continuous renal replacement therapy (CRRT) and therapeutic plasma exchange (TPE). Designed with real-world input from more than 650 healthcare providers around the world, the PrisMax system offers innovative technology to help simplify therapy delivery, while providing hospitals the flexibility to meet the unique demands of the ICU.

“We looked at every detail during the PrisMax design process. Our team reviewed every piece of feedback from nephrologists, nurses and intensive care specialists, and then designed a system that can help simplify therapy administration and maximize efficiency,” said Gavin Campbell, general manager of Baxter’s U.S. renal business. “We put our 20 years of expertise in CRRT and blood filtering technology to work to design an advanced system that allows for clinicians to customize treatment parameters to meet the needs of their patients.”

Building on Baxter’s leading Prismaflex technology currently used by hospitals in more than 90 countries, the PrisMax system is used to treat patients with acute kidney injury (AKI) and select autoimmune diseases. There are approximately five million AKI patients in the U.S. each year, and AKI rates have been on the rise. Data from the 2000–2014 National Inpatient Sample (NIS) and the National Health Interview Surveys (NHIS) show that hospitalization rates for AKI have increased significantly in that period—114 percent among women and 165 percent among men. According to the United States Renal Data System (USRDS), the rate of Medicare fee-for-service beneficiaries experiencing a hospitalization complicated by AKI doubled between 2006 and 2016.1

PrisMax includes new digital health features that allow hospitals to connect the system to electronic medical record (EMR) platforms. This enables straightforward integration of information from PrisMax to the EMR, allowing ICU nurses to spend less time manually documenting treatment data, while reducing the risk of transcription errors. PrisMax also features TrueVueAnalytics, Baxter’s proprietary data and analytics platform. Hospitals can use TrueVue Analytics tools to evaluate data aggregated at the hospital level and assess the quality and effectiveness of their CRRT programs.

Baxter designed the PrisMax system to optimize treatment accuracy and system performance, while making it simpler and more efficient for clinicians to use. Treatment accuracy is a critical component of delivering the benefits of CRRT, and the system uses intelligent pump adjustments to help ensure that fluid removal targets prescribed by the patient’s clinical team are met. PrisMaxalso offers clinicians flexibility for effluent management, with the option of auto-effluent drain or effluent bag drain configurations. Additionally, a prospective, multicenter, international pilot study found 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, how often the blood pump stops, filter life and machine downtime. 2

The TherMax blood warmer, which is used exclusively with the PrisMax system, is an important component for extracorporeal CRRT to warm the blood prior to returning to the body, helping keep the patient’s body temperature at a normal level.

Baxter has launched PrisMax in more than 20 countries across Europe and Australia, and expects to file for regulatory approval of PrisMax in additional countries in 2019 and 2020. – MPO

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