Quanta Dialysis Technologies received FDA 510(k) clearance for the use of its dialysis system in the home. Beverly, Massachusetts–based Quanta said in a news release that the FDA nod makes it the only company offering a high dialysate flow (500 mL/min) system across the entire care continuum for end-stage renal disease (ESRD) patients.
Related: CytexOrtho gets FDA approval for first-in-human trial of absorbable hip implants
The company says its clearance marks a significant step in its U.S. commercialisation efforts. It comes on the heels of clearance for its device for performing intermittent hemodialysis (IHD), sustained low-efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without any need for bags.
Quanta says 2022 data highlights that, of 550,000 prevalent ESRD patients in the country on dialysis therapy, just 2.4% receive home hemodialysis (HHD). Quanta addresses this gap by providing access to a high-flow system in the home. This is the same offering routinely provided in hospitals, post-acute facilities and in-center clinics, the company said.
“The 510(k) clearance embodies the hard work and determination of our exceptional team at Quanta,” said Quanta CEO Alejandro Galindo. “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 U.S. continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimizing complications and readmissions.
“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.”
