Israeli company receives FDA approval on new PD device
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liberDi Ltd., a device company based in Israel, has received regulatory clearance from the FDA to market a new continuous ambulatory peritoneal dialysis machine, according to a press release.
“Receiving FDA clearance for our state-of-the-art Digital Dialysis Clinic technology is a huge achievement for liberDi,” Hezkiah Tsoory, CEO of the company, said in the release. “liberDi's system is designed to provide these patients with ease of use, freedom of movement, automatic catheter connection flush technology and patient monitoring, while performing their daily dialysis activities from the comfort of their home or workplace.”
Tsoory told Healio that the system performs automated PD exchanges in approximately 20 minutes. “liberDi’s Digital Dialysis Clinic is a complete, mobile dialysis system comprised of an [intelligent dialysis assistant] IDA single-use cartridge and IDA smartphone application for use by dialysis patients, simplifying self-dialysis while providing remote supervision by their health care practitioners that use the medical supervision portal, a secure cloud-based platform that allows remote access to complete treatment data and providing pre-defined alerts and insights, as well as personalized treatment options,” Tsoory said.
Clinical studies
liberDi conducted two clinical studies in Israel to demonstrate the safety and effectiveness of the Digital Dialysis Clinic. The first in-human clinical study by the company was completed in 2018 and involved 42 patients performing a single PD exchange at the dialysis clinics. “Initial safety and performance objectives were measured, and the results demonstrated a satisfying safety profile of device usage,” according to the press release.
A second study included 10 patients on both continuous ambulatory PD and 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 per protocol, without any technical issues or device malfunctions. Blood tests were collected from all subjects prior to and following the exchange, without any changes in blood electrolytes or other relevant blood markers from baseline to 2 [to] 4 hours after exchange.
“All exchange parameters were within the specifications of the device and patient's standard exchange parameters, thereby confirming the device's safety and performance characteristics,” according to the report.
Validation study
The company also performed a human factor validation study “evaluating all user groups: people requiring dialysis and their caregivers, as well as health care professionals, such as nephrologists and dialysis nurses,” according to the release. “The study simulated a real-world environment and proved that anyone can operate the system following a single 90-minute proper training session.”
Edwina Brown, MD, president of the International Society for Peritoneal Dialysis and professor of renal medicine at the Imperial College London, said in the release, “This represents an exciting development for peritoneal dialysis and is the first for some years. It makes at-home peritoneal dialysis easier and quicker (due to the pump in the device), and with remote monitoring available for the dialysis center it will make dialysis at home more accessible for the many people globally who develop kidney failure.”
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