Kalos Medical Receives Korean Innovative Medical Device Designation for DENEX Hypertension Treatment System
Wednesday, June 28, 2023
Kalos Medical has announced that South Korea's Ministry of Food and Drug Safety (MFDS) has designated the DENEX hypertension treatment system as an Innovative Medical Device.
The DENEX system is an innovative medical device used for the treatment of hypertension, specifically utilising a minimally invasive procedure called renal denervation. This technology involves the insertion of electrodes into the renal artery through a thin catheter tube, targeting sympathetic nerve locations within the kidneys.
Once the electrodes are properly positioned, the DENEX system applies radiofrequency energy to the arterial wall, thereby inactivating certain portions of the sympathetic nerves. By doing so, the device aims to disrupt the overactive sympathetic nervous system activity, which is often associated with high blood pressure.
The procedure performed with the DENEX system is relatively short and considered safe. Unlike more invasive procedures such as laparoscopic surgery, it does not require general anaesthesia, which can reduce the potential risks and side effects associated with anaesthesia.