January 09, 2023
2 minutes to read
LiberDi Ltd. acquired , a device company based in Israel, has received regulatory authorization from the Food and Drug Administration to market a new continuous ambulatory peritoneal dialysis machine, according to a press release.
“Receiving FDA clearance for our state-of-the-art dialysis clinic technology is a huge achievement for LiberDi, Hezekiah Tzuri The company’s CEO said in the statement. “The LiberDi system is designed to provide these patients with ease of use, freedom of movement, automated catheter delivery flow technology and patient monitoring, while performing daily dialysis activities from their home or workplace.”
Tsuri told Healio that the system performs automated PD exchanges in about 20 minutes. LiberDi’s digital dialysis clinic is a complete mobile dialysis system consisting of… [intelligent dialysis assistant] Single-use IDA cartridge and IDA smartphone app for use by dialysis patients, simplify self-dialysis while providing remote supervision by healthcare practitioners using the Medical Oversight Portal, a secure, cloud-based platform that enables remote access to complete treatment data and providing predefined alerts and insights, as well as personalized treatment options,” said Tsuri.
Clinical studies
conducted by LiberDi Two clinical studies in Israel to demonstrate the safety and effectiveness of a digital dialysis clinic. The company’s first human clinical study was completed in 2018 and included 42 patients undergoing a single PD exchange in dialysis clinics. According to the press release, “Primary safety and performance objectives were measured, and the results demonstrated a satisfactory safety profile for device use.”
The second study included 10 patients in both PD and persistent ambulatory PD at a single center. “No adverse events, serious or otherwise, were reported,” according to an interim study report by the company. All exchanges were performed according to protocol, without any technical problems or machine malfunctions. Blood tests were collected from all subjects before and after the exchange, with no changes in blood electrolytes or other relevant blood markers from baseline to 2 [to] 4 hours after exchange.
According to the report, “All interchange parameters were within device specifications and standard patient interchange parameters, confirming the device’s safety and performance characteristics.”
Verification study
The company also conducted a human factor validation study to “evaluate all user groups: people requiring dialysis and their caregivers, as well as healthcare professionals, such as nephrologists and dialysis nurses,” according to the announcement. “The study simulates a real environment and demonstrated that anyone can operate the system after a single proper training session of 90 minutes.”
edwina brown, MD, President of the International Society of Peritoneal Dialysis and Professor of Nephrology at Imperial College London said in the statement: “This represents an exciting development for peritoneal dialysis and is the first in many years. It makes home dialysis easier and faster (because of the pump in the machine), and with the availability of Remote monitoring of the dialysis center, it will make home dialysis much easier for the many people globally who develop kidney failure.”