Quanta Earns FDA Nod for Expanded CRRT Indication

Quanta Dialysis Technologies has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of its compact hemodialysis device, the Quanta dialysis system.
 
The clearance covers two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF). According to the company, the FDA nod makes it the only dialysis device FDA-cleared for intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED) or bagless CRRT which creates dialysate on demand, all in a single machine.
 
The latest addition of Quanta’s Trinal Kidney Therapy (TKT) software treats critically ill patients diagnosed with acute kidney injury (AKI) who need dialysis. It features dialysate flow rates from 50 to 500 mL/min and treatment times up to 24 hours of continuous delivery.
 
“This clearance is a true game-changer for acute care settings,” Quanta CEO Alejandro Galindo told the press. “Hospitals are often constrained with limited space and nursing staff. The Quanta Dialysis System with TKT software provides an all-in-one solution for hospitals with an intensive care unit (ICU) looking to reduce their device footprint, maximize their operational efficiencies, reduce burden on nurses and substantially lower consumables expenses.”
 
Quanta aims to officially launch the product at the 2023 American Society of Nephrology Annual Meeting.
 
“Critically ill patients that are hemodynamically unstable, such as those with severe AKI, are more challenging to manage in the ICU balancing volume status, inotropic support and ventilation requirements. Because of its slower rate of fluid removal, CRRT may cause less stress for the patient and enable more real-time decision making for clinical teams on a minute-to-minute basis,” added Quanta chief medical officer, Dr. Paul Komenda, MHA, FRCPC, FASN. “However, once the hemodynamic status of the patient has improved, a transition to IHD or SLED may be the best option. A device than can perform all three modalities in one is ideal.”