Quanta Dialysis Technologies has announced that its Quanta Dialysis System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for home hemodialysis. This clearance marks a significant advancement in the treatment of end-stage renal disease (ESRD), offering patients access to high dialysate flow (500 mL/min) dialysis in the comfort of their homes.
This approval follows Quanta's previous FDA clearance for a device capable of performing intermittent hemodialysis (IHD), sustained low-efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without the need for bags, further expanding its capabilities in kidney replacement therapy.
Addressing the Home Hemodialysis Gap
According to 2022 data from the United States Renal Data System, only 2.4% of the 550,000 prevalent ESRD patients in the U.S. receive home hemodialysis (HHD). The Quanta Dialysis System aims to bridge this gap by providing a high-flow system comparable to those used in hospitals and clinics, directly to patients' homes.
"The 510(k) clearance embodies the hard work and determination of our exceptional team at Quanta," said Quanta Chief Executive Officer Alejandro Galindo. He further noted the company's plans to launch the system in homes, starting with customers already familiar with its use in acute and sub-acute settings.
Overcoming Barriers to HHD Adoption
Currently, over 70% of U.S. dialysis facilities are not certified to offer HHD, and nearly half of those with certification have no active HHD patients. This is largely due to a lack of FDA-cleared technologies, high therapy costs, and patient burden associated with low-flow technologies requiring frequent treatments.
Quanta Chief Medical Officer Dr. Paul Komenda, MHA, FRCPC, FASN, emphasized the benefits of home hemodialysis, stating, "Many patients prefer the flexibility of home hemodialysis – a flexible schedule, no commute, and with more frequent therapies they feel better and need less medication." He added that Quanta is committed to making kidney care more accessible with an easy-to-train and maintain device that accommodates a high-flow HD prescription.
Clinical Trial Results
An FDA Investigational Device Exemption (IDE) trial of the Quanta Dialysis System, completed in October 2023, involved a multi-center, open-label assessment of efficacy and safety. In the trial, 32 patients underwent standard in-center hemodialysis while training to use the Quanta Dialysis System, before transitioning to perform HHD four times per week for eight weeks. The study demonstrated the device's safety and effectiveness, with over 90% of patients choosing to continue using it after completing the trial.
Dr. Komenda noted that the IDE study demonstrated best-in-class dialysis adequacy and high patient satisfaction, offering sufficient dialysis in 3x per week therapy and the option of better outcomes with higher frequency.
About the Quanta Dialysis System
The Quanta Dialysis System is a compact device designed to deliver kidney replacement therapy across various care settings. Its intuitive user interface and once-weekly hot rinse requirement make it accessible to a broad range of users, bringing dialysis directly to patients.
