Quanta Dialysis System Gains FDA Clearance for Home Hemodialysis

The U.S. Food and Drug Administration FDA has awarded 510(k) clearance to Quanta Dialysis Technologies’ for use of its Quanta Dialysis System in the home setting. With this clearance, Quanta reportedly becomes the only company to offer a high dialysate flow (500 mL/min) system across the entire care continuum for end-stage renal disease (ESRD) patients.

This step in Quanta’s U.S. commercialization efforts follows another recent milestone in which the company received clearance for the first and only FDA-cleared device able to perform intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED), and CRRT (CVVHD and SCUF) without any need for bags.

Of the 550,000 prevalent U.S. ESRD patients on dialysis therapy, only 2.4% receive home hemodialysis (HHD), according to 2022 data from the United States Renal Data System. The Quanta Dialysis System (previously known as the SC+ Hemodialysis System) addresses this gap by providing patients access to a high-flow system in the home, the same offering as routinely provided in hospitals, post-acute facilities and in-center clinics.

 “The 510(k) clearance embodies the hard work and determination of our team at Quanta,” Quanta 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 U.S. continues to evolve towards value-based care models, the focus for patients with chronic diseases is on minimizing 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.”

Decades-Long Troubles With HHD Adoption

More than 70% of U.S. dialysis facilities are currently not certified to offer HHD, and almost half of those with certification have no active HHD patients due to the lack of FDA-cleared technologies, as well as challenges associated with the cost-of-therapy and patient “burnout” caused by dialyzing with low flow technologies requiring frequent treatments.

“Many patients prefer the flexibility of home hemodialysis—a flexible schedule, no commute, and with more frequent therapies they feel better and need less medication,” Quanta Chief Medical Officer Dr. Paul Komenda, stated. “Expanding treatment into the home is something we are constantly asked about by clinicians, advocacy groups, providers and patients. One of our major commitments as a business is to make kidney care more accessible, and with an easy-to-train, easy-to-maintain device that accommodates a high-flow HD prescription, Quanta is poised to become the best option for the home.”

Encouraging Clinical Trial Results

An FDA Investigational Device Exemption (IDE) trial of the Quanta Dialysis System was completed in October 2023, including a multi-center, open-label assessment of efficacy and safety. In the trial, 32 patients received standard in-center hemodialysis while being trained to use the Quanta Dialysis System, before transitioning to perform HHD four times per week for eight weeks. The study demonstrated the device to be safe and effective, with more than 90% of patients electing to continue using the device after completing the trial.

Study results were presented at the American Society of Nephrology meeting in 2023 and the manuscript is currently under review at the Clinical Journal of the American Society of Nephrology.

“Our IDE study has clearly demonstrated best in class dialysis adequacy and high patient satisfaction. Our device gives sufficient dialysis in 3x per week therapy and the option of better outcomes with higher frequency,” Dr. Komenda noted.

As a compact device with performance comparable to larger traditional machines, the Quanta Dialysis System provides the clinical versatility needed to deliver kidney replacement therapy across multiple care settings. With an intuitive user interface and only once-weekly hot rinse requirement, the device is designed to be operated by a broad range of users to bring dialysis directly to patients.

The Royal Academy of Engineering announced Quanta Dialysis Technologies as the recipient of the 2022 MacRobert Award (the U.K.’s longest running and most prestigious award for U.K. engineering innovation), joining the ranks of Rolls-Royce, Arup and Raspberry Pi.