MFDS designates DeepCure's 'HyperCure' as innovative medical device... Hypertension treatment product

The Ministry of Food and Drug Safety announced on the 5th that it has designated DeepCure's 'HyperQure,' consisting of a universal electrosurgical device for renal nerve ablation and a disposable hand-controlled electrosurgical electrode, as the 36th innovative medical device.

DeepCure's HyperQure, designated as an innovative medical device. [Photo by Ministry of Food and Drug Safety]

This product is the first domestic device designed to treat hypertension by wrapping around the outside of the renal artery in a curved shape that considers the artery's form, blocking the sympathetic nerves distributed on the outer wall of the blood vessel with radiofrequency energy.

It has been recognized as a new treatment method for patients with resistant hypertension who do not respond to drug therapy and was designated as an innovative medical device. Clinical improvement potential was confirmed in animal tests, and exploratory clinical trials are currently underway.

Meanwhile, the Ministry of Food and Drug Safety has designated a total of 36 products as innovative medical devices to date. The ministry stated, "To support the rapid commercialization of innovative medical devices, we will strive to provide safe and new treatment technologies to the public quickly through close support such as priority reviews."

This content was produced with the assistance of AI translation services.