Quanta Dialysis Technologies receives FDA clearance for updated hemodialysis device
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Key takeaways:
- The Quanta Dialysis device supports two modes of continuous renal replacement therapy.
- It provides dialysate flow rates of 50 to 500 mL/min and treatment times of up to 24 hours.
Quanta Dialysis Technologies has received FDA 510(k) clearance for an expanded version of the Quanta Dialysis System hemodialysis device, according to a press release.
“Hospitals are often constrained with limited space and nursing staff. The Quanta Dialysis System provides an all-in-one solution for hospitals with an intensive care unit looking to reduce their device footprint, maximize their operational efficiencies, reduce burden on nurses and substantially lower consumables expenses,” Alejandro Galindo, CEO of Quanta, said in a company press release.
The Quanta Dialysis System is designed to treat critically ill patients with AKI who need dialysis. As a slower and gentler alternative to conventional dialysis, it provides dialysate flow rates of 50 mL/min to 500 mL/min and treatment times of up to 24 hours, according to the release.
The latest edition of its Trinal Kidney Therapy software supports two modes of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis and slow continuous ultrafiltration. The tool provides intermittent hemodialysis, sustained low-efficiency dialysis or bagless CRRT, researchers wrote in the release.
"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,” Paul Komenda, MHA, FRCPC, FASN, chief medical officer of Quanta, said in the release. “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.”
The company is prepared to commercialize the device with the new software and expects to launch the device at the American Society of Nephrology Annual Meeting in November.
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