Kalos Medical's DENEX Hypertension Treatment System Receives Korean MFDS Innovative Medical Device Designation

Revolutionizing Hypertension Treatment: Kalos Medical's DENEX System Recognized for Innovation by Korean MFDS

Kalos Medical Inc., a developer of innovative medical devices treating hypertension and other chronic illnesses, announced that South Korea’s Ministry of Food and Drug Safety (“MFDS”) designated the company’s DENEX hypertension treatment system as an Innovative Medical Device, a designation that recognizes medical devices that significantly improve safety and efficacy compared to existing medical devices and treatments.

The DENEX system is an innovative medical device that treats hypertension using minimally invasive renal denervation technology. Electrodes are inserted into the renal artery through a thin catheter tube to sympathetic nerve locations in the kidneys. The device then uses radiofrequency energy applied to the arterial wall to inactivate portions of the sympathetic nerves, which has been demonstrated to be effective at lowering blood pressure. Unlike laparoscopic surgery, the DENEX system procedure is short and safe, without the negative side effects associated with general anesthesia.

Similar to the U.S. Food and Drug Administration’s Breakthrough Device designation, the Innovative Medical Device designation is MFDS’s formal recognition of high-value medical devices that have the potential to provide more effective treatment of serious medical conditions than the current standard of care. The MFDS, in consultation with South Korea’s Ministry of Health and Welfare and other related ministries, selects medical devices for the designation, which grants special benefits such as priority MFDS review.

Peter Chang, CEO of Kalos Medical, remarked, "We are delighted to have received the Innovative Medical Device designation and, with it, the recognition that the DENEX renal denervation system is an innovative, high technology solution, with improved safety and efficacy compared to existing hypertension treatments."

Published on : 28th June, 2023