On the 30th, the Inter-Agency Project Team for Research and Development of Medical Devices announced that domestic blood dialysis filters have begun to be prescribed for use in clinical settings.
Blood dialysis filters are essential medical devices for dialysis patients. For the past several decades, products from the United States, Europe, and Japan have been completely imported for use, but with the support of the project team and research cooperation among hospitals, schools, and corporations, localization has succeeded.
A research team led by Professor Kim Dong-gi from Seoul National University Hospital's Department of Nephrology confirmed the efficacy and safety of the blood dialysis filters through several years of large animal preclinical trials. Subsequently, over the past year, multicenter clinical trials of domestic blood dialysis filters were conducted at five hospitals, including Seoul National University Hospital, Sang Gye Paik Hospital, Chung Ang University Hospital, Chung Ang University Gwangmyeong Hospital, and SNUH SMG-SNU Boramae Medical Center.
This clinical trial compared and analyzed the Synoflux® filter developed by domestic corporations, Synopex, with the most widely used product globally from Germany.
The researchers compared key indicators that are essential for the management of dialysis patients, such as ▲urea removal rate (URR), ▲spKt/V (adequacy of dialysis), ▲removal rates of middle molecular uremic toxins (including β2-microglobulin, Cystatin C, Prolactin, Myoglobin, etc.), and ▲safety indicators (albumin preservation, incidence of adverse reactions, etc.).
As a result, the domestic filters exhibited equal or superior performance in the removal efficiency of small molecular toxins compared to global commercial products. In terms of the efficiency of removing middle molecular toxins, which significantly impacts the survival rate of dialysis patients, it yielded even better results.
In terms of safety evaluation indicators such as albumin loss, hypotension, and thrombosis, it also demonstrated safety that is on par with existing global products.
Kim Beom-min, head of the Inter-Agency Project Team for Research and Development of Medical Devices, noted, "This development project is the first case to be recognized internationally as providing academic and clinical evidence that a blood dialysis filter developed domestically matches or even exceeds the performance of commercially available products from global suppliers in advanced countries."
Professor Kim Dong-gi from Seoul National University Hospital stated, "It is significant in that it proves Korea can carry out the entire cycle of medical device development from the development stage to clinical trials and actual clinical application." He added, "With the successful localization of blood dialysis filters, we can now secure the stability of blood dialysis treatment even in crisis situations like supply chain crises or pandemics, which gives me great satisfaction."