Carlos Medical Launches European Clinical Trials for Hypertension Medical Device 'Dineks'

Medical staff are taking a commemorative photo after the procedure of the first registered patient in the DineX Europe clinical study at Hippocrates General Hospital in Athens, Greece. (Photo by Carlos Medical)

[Asia Economy Reporter Chunhee Lee] Carlos Medical announced on the 26th that the first patient in the exploratory clinical trial of the hypertension treatment medical device ‘DENEX’ has been enrolled and the procedure completed in Greece.

The exploratory clinical trial named EUPILOS is being conducted at 20 institutions across four European countries: Greece, Germany, Italy, and Poland. Patient recruitment began last September, and a total of 100 patients are planned to be enrolled by the first quarter of 2024. Eligible patients are adults aged 18 to under 80 years who are either not taking antihypertensive medication or can discontinue such medication during the study period. Safety and efficacy data will be collected by comparing the renal denervation (RDN) procedure group using DENEX with the sham procedure control group.

Unlike pharmaceutical clinical trials, which typically undergo three phases from Phase 1 to Phase 3, medical device trials are conducted in two stages: exploratory trials for initial research purposes and confirmatory trials for product commercialization.

DENEX is a renal nerve denervation medical device for hypertension treatment, which involves inserting a thin catheter with electrodes into the renal artery. Radiofrequency energy is used to deactivate the sympathetic nerves of the renal artery to lower blood pressure. Renal nerve denervation using a catheter like DENEX is a minimally invasive interventional procedure that, unlike laparoscopic surgery, has a relatively short procedure time, is safe, and avoids the risks associated with general anesthesia.

Hyun Mi-sook, Chief Clinical Officer (CCO) of Carlos Medical, said, “We are very pleased that the clinical trial in four European countries has started smoothly. Given that randomized controlled trials conducted over the past few years have secured the blood pressure-lowering effect and safety of renal nerve denervation, we expect good results from this trial as well.”

Carlos Medical is currently conducting confirmatory clinical trials for domestic approval of DENEX. They plan to recruit 148 patients at 30 institutions, including Seoul St. Mary’s Hospital, by early next year and announce the first efficacy evaluation results in July.

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