Fresenius Medical Care North America (FMCNA) recently announced FDA clearances for two of its technologies used in dialysis care.
Today, the Waltham, Massachusetts-based company announced FDA clearance for the AquaA water system. The company designed it as a water purification system for hemodialysis.
Yesterday, the FDA granted 510(k) clearance to upgrade Fresenius’ Liberty Select cycler. Clearance enables remote therapy with the Kinexus therapy management platform. It aims to elevate the home therapy experience for peritoneal dialysis (PD) patients and clinicians.
AquaA uses advanced technology to optimize water and power usage with full heat disinfection. It offers customization capabilities for the unique needs of each dialysis center. AquaA uses reverse osmosis (RO) to remove organic and inorganic substances and microbial contaminants from the water. Its intelligent technology and resource-efficient design provide low maintenance requirements and flexibility across multiple clinical settings.
The company expects to make AquaA available this year with widespread inventory available in the first half of 2023.
“This new water treatment system seeks to make heat disinfection an industry standard by providing an innovative and flexible system,” said Pat McCarthy, SVP 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.”
Remote therapy capabilities
Liberty Select with Kinexus assists home dialysis clinicians. It helps make critical, informed decisions from accurate, timely treatment data summaries. Care teams also receive access to up to 90 days of treatment data history.
Fresenius plans to make upgrades available to Liberty Select cyclers in the market to enable remote therapy management.
“This is the latest in a series of significant innovations in our portfolio of home dialysis machines that we believe will play a critical role in accelerating the adoption of home therapies and improving patient outcomes,” said Joe Turk, global head of Home Therapies at Fresenius Medical Care. “Our new PD system has remote therapy management capabilities allowing clinicians to modify the patients’ therapy program remotely, helping patients reduce in-person appointments.”
Liberty Select with Kinexus offers simplicity, safety and connectivity. It makes for a more personalized therapy experience, Fresenius said. It features daily patient health inputs and customizable drain options. The system offers flow alert options for reducing alarms and alerts at night, plus more visibility to total ultrafiltration.
The cycler has an intuitive user interface on a large, color touchscreen. It offers step-by-step instructions for setup, treatment and troubleshooting.
“We expect these new features will make patients more willing to try peritoneal dialysis and find success, ultimately improving their quality of life,” said Dr. Dinesh Chatoth, associate CMO for Fresenius Kidney Care. “As a result of these updates, providers can more easily make timely prescription changes in the first several months of PD therapy, which our research shows may reduce attrition rates among patients by almost 90%.”