Quanta Dialysis Technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Quanta Dialysis System for home use.
The Quanta Dialysis System is a compact device that delivers performance comparable to larger machines, offering versatile kidney replacement therapy across multiple care settings.
Featuring an intuitive user interface and a once-weekly hot rinse, it is designed for use by a wide range of patients and caregivers, bringing dialysis directly to the home.
Quanta Dialysis Technologies recently received FDA clearance for the first device capable of performing intermittent haemodialysis (IHD), sustained low-efficiency dialysis (SLED), and continuous renal replacement therapy (CRRT), including CVVHD and SCUF, without the need for bags.
This latest approval allows the Massachusetts–based firm to offer a high dialysate flow (500 mL/min) system for end-stage renal disease (ESRD) patients across all care settings.
The Quanta Dialysis System, formerly known as the SC+ Hemodialysis System, is indicated for patients with acute or chronic renal failure, with or without ultrafiltration, in both acute and chronic care settings.
It features the SC+ Blood Tube Set, a single-use, disposable arterial and venous bloodline set that provides extracorporeal access during haemodialysis. It is specifically designed for compatibility with the SC+ Hemodialysis System.
Quanta Dialysis Technologies CEO Alejandro Galindo said: “We recruited and executed this pivotal trial during the height of Covid-19 and have now achieved an FDA clearance few other products have obtained.
“As the US continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimising complications and re-admissions.”
“Our product is designed to help those patients seamlessly transition to the home and remain there as long as possible. We are currently planning our home launch with customers who have successfully implemented Quanta into acute and sub-acute settings first.”
The approval was supported by the results from an FDA investigational device exemption (IDE) trial of the Quanta Dialysis System, completed in October 2023.
This multi-centre, open-label study assessed the device’s efficacy and safety. Initially, 32 patients received standard in-centre haemodialysis while training to use the Quanta Dialysis System.
After training, they transitioned to home haemodialysis four times a week for eight weeks.
The trial showed the system to be both safe and effective, with over 90% of patients choosing to continue using the device after the study.
