DeepCure's Laparoscopic RDN Device 'HyperCure' Begins US Clinical Trials: "First Patient Surgery Completed"

DeepCure announced on the 20th that it has completed the first patient surgery in the United States clinical trial of HyperQure, the world's first laparoscopic renal denervation (RDN) device.

The surgery was performed on the 17th of this month (local time) at the University of California, Irvine (UC Irvine) campus, led by Professor Pengbo Jiang, with DeepCure officials also in attendance. Notably, this was the first domestic and international clinical trial of HyperQure to use a single-port robot (da Vinci SP) for the surgery.

HyperQure is a resistant hypertension treatment device that uses a laparoscopic method to apply a radio frequency (RF) electrode device in contact with the renal artery to block the sympathetic nerves. It can treat resistant hypertension by perfectly blocking the renal nerves without damaging the patient's vascular endothelium. Currently, clinical trials are being conducted simultaneously in South Korea and the United States, aiming for approval as the world's first laparoscopic RDN device.

The U.S. clinical trials are being conducted not only at the University of California, Irvine campus but also at seven major university hospitals across the United States. After completing IRB (Institutional Review Board) approval for the trials, the plan is to register 15 clinical patients by the first half of the year. Subsequently, the goal is to apply for the U.S. pivotal study by the end of this year to confirm the safety and efficacy of the medical device.

A DeepCure official stated, "Just like the smoothly progressing domestic clinical trials, the U.S. clinical trial has also successfully completed the first patient surgery," adding, "Especially with the success of this surgery using the single-port robot for the first time, the utilization of HyperQure will expand, and the clinical progress will accelerate."

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