Baxter International Receives FDA Approval for Next-Generation PrisMax CRRT and TherMax Plasma Exchange Systems

On July 31, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that medical technology company Baxter International announced that its PrisMax system and TherMax blood warmer had received FDA approval. The two products are new devices for continuous renal replacement therapy (CRRT) and therapeutic plasma exchange (TPE).

Previously, the PrisMax system has been launched in more than 20 countries and regions across Europe and Australia for the treatment of kidney diseases.

Baxter, founded in 1931 and headquartered in Illinois, USA, is a leading medical technology company. The company is dedicated to developing pharmaceuticals, medical devices, and novel therapies, primarily for the treatment of hemophilia, immune system disorders, infectious diseases, kidney diseases, and other acute and chronic conditions. Baxter was listed on the New York Stock Exchange (NYSE) in January 1978.

For kidney disease, Baxter also collaborates with medical device R&D companies such as DEKA Research and Development to develop home hemodialysis machines, providing advanced treatment equipment for hospitals, kidney dialysis centers, nursing homes, rehabilitation centers, and medical research laboratories.

The PrisMax system, based on Baxter’s patented Prismaflex technology, is primarily used for the treatment of acute kidney injury (AKI), continuous renal replacement therapy (CRRT), and autoimmune diseases. There are approximately 5 million AKI patients in the United States each year, with prevalence rising annually. According to data from the Nationwide Inpatient Sample (NIS) and the National Health Interview Survey (NHIS), the hospitalization rate for AKI patients increased by more than 110% between 2000 and 2014.

The PrisMax system is designed to enhance therapeutic efficacy and treatment accuracy, while helping clinicians streamline their workflows. Treatment accuracy is a key determinant of the efficacy of continuous renal replacement therapy (CRRT). The system utilizes intelligent pumps to regulate dialysate flow rates and maintain homeostasis. Clinical studies have demonstrated that the PrisMax system significantly outperforms comparable devices in terms of treatment efficiency and ease of operation.

The PrisMax system also includes digital health capabilities that support integration with hospital data systems and electronic medical record (EMR) platforms. This feature enables direct consolidation of patients’ relevant treatment information, helping to improve data recording efficiency and reduce the risk of transcription errors. The PrisMax system also incorporates Baxter’s proprietary TrueVue Analytics data analysis platform, which helps hospitals aggregate patient medical data and evaluate the effectiveness of CRRT treatment regimens.

The TherMax blood warmer is specifically designed to assist the PrisMax system by heating purified blood during treatment before it is returned to the patient’s body, playing a crucial role in maintaining normal body temperature.

Gavin Campbell, General Manager of Baxter’s Kidney Care business, stated, “We focused on every detail in the design process of PrisMax. Our team engaged in in-depth discussions with nephrologists, nurses, and critical care specialists before deciding to design this system to streamline treatment workflows and enhance therapeutic efficiency. Baxter’s team of experts brings over 20 years of experience in CRRT and hemofiltration technologies, and we are committed to developing advanced medical technologies to meet patient needs.”

(Compiled by Xu Xiaoxue)