The government ordered Baxter to suspend the sale of Theranova, a blood filter for artificial kidney, for 15 days because of a comparative advertisement where the company said its hemodialyzer was better than other competitors.
The Ministry of Food and Drug Safety made the instruction on Monday, mandating the sales suspension of Theranova for 15 days from Wednesday to Jan. 30.
Released in Korea in 2017, Theranova is used for hemodialysis in patients with chronic and acute renal failure.
According to Baxter, the device offers expanded hemodialysis, or HDx, which can remove not only small middle molecules but also large middle molecules. Thus, Theranova’s filtration is almost similar to that of a real kidney, the company said.
Compared to conventional hemodialysis, Theranova’s HDx improved the quality of hemodialysis and can be applied to almost all hemodialysis machines, according to Baxter. HDx is as simple as traditional hemodialysis and does not require a particular device or a large amount of dialysis fluids, the company said.
However, the ministry discovered that Baxter’s ad of Theranova included an unauthorized content that said its product was superior to other dialyzers.
Under the Medical Devices Act’s Article 2, Provision 2 and 3, a company is subject to punishment if it promotes any performance, efficacy, or effect not included in the permission or certification granted.