DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX), a global leader in acute care, announced today 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% among women and 165% 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 TrueVue Analytics, 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. PrisMax also 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.
Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.
Rx Only. For safe and proper use of this device, refer to the full Instructions for Use.
This release includes forward-looking statements concerning PrisMax and TherMax, including potential benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Baxter, PrisMax, TherMax, TrueVue Analytics and Prismaflex are registered trademarks of Baxter International Inc.
1USRDS ADR 2018:Vol 1 Chronic Kidney Disease in the United States, Chap 5.
2Broman M, et al. Blood Purif. 2018;46:220-227.