A new treatment option has been introduced in Korea for patients with hypertension whose blood pressure is hard to control despite medication and lifestyle changes.
The Ministery of Food and Drug Safety said on the 5th that it has authorized an ultrasound surgical device for renal nerve denervation as a newly developed medical device, to be used as an adjunct to lower blood pressure in patients with resistant hypertension.
Renal nerve denervation is a procedure that lowers blood pressure by blocking the activity of sympathetic nerves around the renal artery. The product authorized this time works by inserting a catheter through the femoral artery and using heat from ultrasound energy generated by the transducer inside the catheter to block the sympathetic nerves around the renal artery.
The Ministery of Food and Drug Safety explained that the product qualifies as a newly developed medical device because its mechanism of action and method of use differ from existing medical devices authorized in Korea.
In clinical trials, the systolic blood pressure of the patient group whose sympathetic nerve activity around the renal artery was blocked with ultrasound energy decreased by an average of 8.16 mmHg. This is 5.8 mmHg lower than the control group's average reduction of 2.36 mmHg.
The Ministery of Food and Drug Safety concluded from this that renal nerve denervation showed a significant effect in reducing blood pressure.