Fresenius Medical Care North America Announces FDA Clearance of New Heat Purification System for Hemodialysis Water with Industry-Leading Efficiency

Friday, November 04, 2022

Fresenius Medical Care North America's (FMCNA) Renal Therapies Group announced today that the U.S. Food and Drug Administration (FDA) has cleared the AquaA™ water system, one of the industry's most efficient water purification systems available for hemodialysis. The new system, from the nation's leading dialysis products company, uses advanced technology to optimize water and power usage with full heat disinfection, while being customizable to the unique needs of each dialysis center.

"This new water treatment system seeks to make heat disinfection an industry standard by providing an innovative and flexible system," said Pat McCarthy, Senior Vice President of FMCNA's Renal Therapies Group. "Water is an essential component of dialysis and we are excited to introduce these remarkable innovations that reduce cost and create efficiencies for our customers."

The AquaA system uses reverse osmosis (RO) to remove organic and inorganic substances and microbial contaminants from the water required for hemodialysis treatment. The new AquaA RO system uses intelligent technology and a resource-efficient design that has low maintenance requirements so it can work in multiple clinical settings.

The innovative features of the AquaA water system include:

• Full heat disinfection: The system fully automates heat disinfection, making chemicals obsolete for routine system disinfections while adding the capability to supply a hot rinse for up to 35 hemodialysis devices in one process.
• Water and energy saving: AquaA minimizes water intake and leads the industry in efficiency with an up-to-85-percent water recovery rate. Smart monitoring automatically detects suboptimal water and energy consumption and adjusts accordingly to save energy.
• Intelligent technology: The intuitive design, user-friendly touch screen display and remote monitoring enable access to the right information at the right time.
• Expanded functionality: The modular system fits in a flexible footprint to meet each center's unique needs. One AquaA system has the capacity to supply up to 75 dialysis stations with product water at 800 mL per minute consumption flow.
• Enhanced safety: With full heat disinfection, patients are assured ANSI/AAMI-quality water for their treatments. Added redundancy of the double-stage RO water system ensures uninterrupted treatments during an emergency and minimal downtime.

"We are excited to help lead the way in heat disinfection, reducing the use of chemicals and ensuring for our patients that this new system creates the highest industry standard for safety," said Dr. Mike Anger, Chief Medical Officer of FMCNA's Renal Therapies Group.

This new system is the latest in a series of water system innovations from FMCNA that include the AquaBplus™ and AquaC UNO H™, which were both introduced in late 2019. The company expects to have availability of the AquaA this year with more widespread inventory in the first half of 2023.