DeepQure has secured approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for the single-arm trial of its laparoscopic renal denervation (RDN) system, HyperQure, aimed at treating atrial fibrillation (AF).
This prospective, multi-centre, open-label exploratory trial will focus on assessing the efficacy and safety of the RDN system in individuals who have recurrent AF after pulmonary vein isolation (PVI) and resistant hypertension.
Developed under the leadership of Seoul National University Hospital professor Chang-Wook Jeong, the HyperQure RDN system is said to adopt an extravascular approach, providing direct anatomical access to renal nerves with the potential for enhanced outcomes.
In addition to the upcoming trial for AF, DeepQure is carrying out RDN trials for resistant hypertension in the US and South Korea.
The company is close to completing subject enrolment for its domestic trials while studies are progressing at five US academic medical centres.
The device has achieved ISO 13485 and GMP certifications.
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By GlobalDataRDN is a minimally invasive procedure that ablates the renal artery nerves to decrease blood pressure, offering a non-drug treatment option for hypertension and resistant hypertension.
A DeepQure spokesperson commented: “This approval validates HyperQure as a next-generation solution that overcomes the limitations of traditional RDN techniques.
“With parallel trials in resistant hypertension and now atrial fibrillation, we are accelerating our push into the global cardiovascular market with a truly differentiated solution.”
In January 2025, the company completed its inaugural clinical case at the University of California, US.
UC Irvine Health urologist Dr Pengbo Jiang performed the procedure, which resulted in notable decreases in the patient’s blood pressure a month following the surgery, without any complications reported.
