UK-based Quanta Fluid Solutions Ltd said it has successfully treated the first patients with SC+, its portable, cartridge-based hemodialysis system. The treatments were part of a pilot study designed to demonstrate safety, performance and usability of SC+ in a clinical setting with human dialysis patients. The results showed that all dialysis therapies were successfully and safely completed with no adverse events.
Essential performance criteria, including urea clearance and ultrafiltration rate, were assessed and achieved their prescribed targets, meeting the primary endpoints of the study.
The first ten treatments were performed with six patients over a two-week period at Nottingham University Hospitals NHS Trust in the United Kingdom. These treatments were provided as in-center, nurse-led hemodialysis therapy sessions at standard dialysate and blood flow-rates. Participants included male and female patients with end-stage renal disease, aged from 40 to 79 years-old and with weights ranging between 79.5kg and 154kg.
Since the study, patients have continued to be treated with the device at Nottingham, reaching over 40 successful treatments to date.
About the SC+
SC+ is a compact, portable, compact hemodialysis system capable of operating at the higher flow rates typically used to treat patients in-center by traditional machines. The machine uses a drop in cartridge that includes fluid mixing circuitry and requires no pre-mixing of dialysate. The cartridge is disposed after every treatment, and eliminates the need for disinfection between patients.