Quanta™ Secures FDA 510(k) Clearance to Broaden Indication for Continuous Renal Replacement Therapies

Friday, August 04, 2023

Quanta Dialysis Technologies, a medical technology company focused on improving kidney care access, recently announced that it has obtained FDA 510(k) clearance for an expanded indication of the Quanta Dialysis System. This innovative and user-friendly hemodialysis device is now approved to offer two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF). With the new FDA clearance, the Quanta Dialysis System becomes the only dialysis device authorized to provide intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED), or bagless CRRT - all in one machine.

Originally designed to serve more than two million people worldwide suffering from end-stage kidney disease (ESKD) who undergo dialysis treatment or kidney transplants, the Quanta Dialysis System has been expanded to include its Trinal Kidney Therapy™ (TKT) software. This latest software addition offers a treatment solution for critically ill patients diagnosed with acute kidney injury (AKI) who require dialysis. It provides dialysate flow rates ranging from 50 to 500 mL/min and allows for treatment times of up to 24 hours of continuous delivery.

The Quanta Dialysis System with TKT software provides an all-in-one solution for hospitals with intensive care units (ICUs) seeking to reduce their device footprint, improve operational efficiencies, decrease the burden on nurses, and significantly lower consumables expenses. ICU patients with severe AKI requiring dialysis have experienced mortality rates exceeding 50%, often necessitating intravenous life support to maintain minimum blood pressure. CRRT offers a slower and gentler alternative to traditional dialysis, operating 24 hours a day and enabling better real-time management of volume and biochemistry for patients. This slower fluid removal rate may cause less stress for critically ill patients, allowing clinical teams to make more real-time decisions on a minute-to-minute basis, considering volume status, inotropic support, and ventilation requirements.



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