Today, Quanta Dialysis Technologies®, a dedicated medical technology company focused on improving kidney care accessibility, announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA). This submission aims to expand the indications for the Quanta™ Dialysis System, an easy-to-use and compact hemodialysis device. Currently, the Quanta Dialysis System is approved for use in chronic and acute care settings, and the new submission seeks to include self-care, in-home hemodialysis.

According to data from the U.S. Renal Data System, there are more than 490,000 individuals in the U.S. relying on hemodialysis for end-stage kidney disease (ESKD) treatment. Home hemodialysis (HHD), which eliminates the need for patients to travel to a dialysis clinic three times a week, constitutes 2% of the total hemodialysis population. Research indicates that HHD offers numerous advantages over traditional in-center dialysis, including enhanced quality of life, improved health outcomes, and better access to care. Responding to the benefits of HHD, the Centers for Medicare and Medicaid Services (CMS) established a program to promote increased use of home dialysis and kidney transplants for Medicare beneficiaries.

Alejandro Galindo, Quanta's Chief Executive Officer, expressed, "The FDA submission for in-home use of the Quanta Dialysis System represents a significant milestone for Quanta in our journey to make dialysis more accessible to every patient in every setting. The Quanta Dialysis System is already providing patients in the U.K. with the freedom and flexibility that HHD offers. With clearance of this 510(k), patients in the U.S. will have more control over their care, and choice in where, when and how they receive treatment."

Upon receiving regulatory clearance from the FDA, this submission would mark the Quanta Dialysis System as the third device in the United States approved for HHD in patients with end-stage kidney disease (ESKD). The clearance for this expanded indication is anticipated in 2024.

Quanta's 510(k) submission is bolstered by clinical data from its Home Run™ study, a prospective, multi-center, open-label trial assessing the efficacy and safety of the Quanta Dialysis System for HHD. Comprehensive results from the study will be presented in November during a poster presentation at the upcoming American Society of Nephrology (ASN) Kidney Week in Philadelphia, Pennsylvania.

 

Source: prnewswire.com

Report Abuse