- Baxter International said it received CE mark approval in Europe for advanced versions of its continuous renal replacement therapy (CRRT) and blood warmer technologies.
- The CRRT system, called PrisMax, builds on the company’s Prismaflex technology for removing waste products and excess fluids from critically ill patients and managing acute kidney injury and sepsis.
- The TherMax blood warmer works with the PrisMax system to adjust the temperature of blood purified outside of the body before it is returned to the patient.
Baxter is the market leader in continuous renal replacement therapy, and the PrisMax launch is a key event for its $456 million acute therapies business. The Deerfield, Illinois-based hospital products giant said it plans to launch PrisMax and TherMax in more than 19 countries across Europe, starting with Denmark, France, Italy and Sweden.
The company is looking to keep the momentum going with a U.S. launch as well. Baxter last week said it submitted a premarket application to FDA seeking 510(k) clearance to roll out PrisMax in the United States.
Baxter has been in the CRRT business for more than 20 years, and its Prismaflex device is used by hospitals in more than 90 countries. CRRT is a slow form of hemodialysis in which the patient's blood is removed and pumped through a filter, then returned into the patient’s circulatory system.
The latest version of the technology, PrisMax is intended to improve on both accuracy and user friendliness, making it easier to treat patients including those experiencing acute kidney injury in the intensive care unit (ICU). Acute kidney injury is a rapid decline in renal filtration function, unlike chronic kidney disease, which occurs slowly over time.
A pilot study comparing PrisMax to predecessor Prismaflex found significant improvements in time needed for bag changes, number of informational and malfunction alarms, how often the blood pump stopped, filter life and machine downtime. The findings were published in the journal Blood Purification.
"Our assessment of the PrisMax system across seven ICUs in six countries concluded that the device features several important enhancements that contribute to safety, efficiency and user friendliness. The launch of PrisMax is a big step forward for clinicians' abilities to treat patients in the ICU more effectively," Marcus Broman of the department of perioperative and intensive care at Skåne University Hospital in Lund, Sweden, and lead author of the study, said in a statement.
The TherMax blood warmer also includes several patient safety features to help control blood return temperature, detect leaks and ensure the correct setup, Baxter said.
In January, Baxter filed a lawsuit alleging rival B. Braun Medical’s Omni system infringes a patent covering Prismaflex.